Trial Outcomes & Findings for Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy as Neoadjuvant Treatment for Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-173/KEYNOTE-173) (NCT NCT02622074)
NCT ID: NCT02622074
Last Updated: 2020-09-10
Results Overview
The following events, if considered to be study-treatment-related by the Investigator, were considered a DLT: * Hematologic: * Grade 4 neutropenia lasting ≥8 days; * Febrile neutropenia Grade 3 or Grade 4; or * Grade 4 thrombocytopenia requiring platelet transfusion, or Grade 3 thrombocytopenia with bleeding * Non-hematologic: * Grade 4 toxicity; * Grade ≥3 symptomatic hepatic toxicities lasting \>48 hours, or Grade ≥3 asymptomatic hepatic toxicities lasting ≥7 days; or * Grade ≥3 non-hematologic, non-hepatic organ toxicity, with exceptions * Other: * Any treatment delays for ≥14 days due to unresolved toxicity; * Grade 5 treatment-related adverse event (AE); * A dose reduction of study treatment during the DLT evaluation period.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Cycle 1 Day 1 through end of Cycle 3 and Cycle 6 Day 1 through end of Cycle 7 (Up to ~150 days from first dose of first combination regimen); Each cycle was 21 days.
Results posted on
2020-09-10
Participant Flow
Sixty participants were allocated and treated on study.
Participant milestones
| Measure |
Cohort A: KNp / KAC
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort B: KNpCb (Regimen 1) / KAC
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort C: KNpCb (Regimen 2) / KAC
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort D: KNpCb (Regimen 3) / KAC
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort E: KTCb (Regimen 1) / KAC
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort F: KTCb (Regimen 2) / KAC
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
6
|
9
|
10
|
9
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort A: KNp / KAC
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort B: KNpCb (Regimen 1) / KAC
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort C: KNpCb (Regimen 2) / KAC
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort D: KNpCb (Regimen 3) / KAC
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort E: KTCb (Regimen 1) / KAC
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort F: KTCb (Regimen 2) / KAC
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
4
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy as Neoadjuvant Treatment for Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-173/KEYNOTE-173)
Baseline characteristics by cohort
| Measure |
Cohort A: KNp / KAC
n=10 Participants
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort B: KNpCb (Regimen 1) / KAC
n=10 Participants
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort C: KNpCb (Regimen 2) / KAC
n=10 Participants
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort D: KNpCb (Regimen 3) / KAC
n=10 Participants
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort E: KTCb (Regimen 1) / KAC
n=10 Participants
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort F: KTCb (Regimen 2) / KAC
n=10 Participants
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.5 Years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
49.5 Years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
43.2 Years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
42.3 Years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
56.7 Years
STANDARD_DEVIATION 11.9 • n=21 Participants
|
52.1 Years
STANDARD_DEVIATION 11.3 • n=10 Participants
|
49.2 Years
STANDARD_DEVIATION 11.4 • n=115 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
60 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
57 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
39 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 through end of Cycle 3 and Cycle 6 Day 1 through end of Cycle 7 (Up to ~150 days from first dose of first combination regimen); Each cycle was 21 days.Population: The DLT evaluable population consisted of all participants who received ≥1 dose of study treatment.
The following events, if considered to be study-treatment-related by the Investigator, were considered a DLT: * Hematologic: * Grade 4 neutropenia lasting ≥8 days; * Febrile neutropenia Grade 3 or Grade 4; or * Grade 4 thrombocytopenia requiring platelet transfusion, or Grade 3 thrombocytopenia with bleeding * Non-hematologic: * Grade 4 toxicity; * Grade ≥3 symptomatic hepatic toxicities lasting \>48 hours, or Grade ≥3 asymptomatic hepatic toxicities lasting ≥7 days; or * Grade ≥3 non-hematologic, non-hepatic organ toxicity, with exceptions * Other: * Any treatment delays for ≥14 days due to unresolved toxicity; * Grade 5 treatment-related adverse event (AE); * A dose reduction of study treatment during the DLT evaluation period.
Outcome measures
| Measure |
Cohort D: KNpCb (Regimen 3) / KAC
n=10 Participants
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort E: KTCb (Regimen 1) / KAC
n=10 Participants
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort F: KTCb (Regimen 2) / KAC
n=10 Participants
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort A: KNp / KAC
n=10 Participants
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort B: KNpCb (Regimen 1) / KAC
n=10 Participants
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort C: KNpCb (Regimen 2) / KAC
n=10 Participants
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)
|
6 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 28 months (through Interim database cut-off date of 31-May-2018)Population: The safety population consisted of all participants who received ≥1 dose of study treatment.
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE either prior to or after definitive surgery is presented.
Outcome measures
| Measure |
Cohort D: KNpCb (Regimen 3) / KAC
n=10 Participants
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort E: KTCb (Regimen 1) / KAC
n=10 Participants
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort F: KTCb (Regimen 2) / KAC
n=10 Participants
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort A: KNp / KAC
n=10 Participants
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort B: KNpCb (Regimen 1) / KAC
n=10 Participants
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort C: KNpCb (Regimen 2) / KAC
n=10 Participants
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
10 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 28 months (through Interim database cut-off date of 31-May-2018)Population: The safety population consisted of all participants who received ≥1 dose of study treatment.
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE is presented.
Outcome measures
| Measure |
Cohort D: KNpCb (Regimen 3) / KAC
n=10 Participants
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort E: KTCb (Regimen 1) / KAC
n=10 Participants
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort F: KTCb (Regimen 2) / KAC
n=10 Participants
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort A: KNp / KAC
n=10 Participants
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort B: KNpCb (Regimen 1) / KAC
n=10 Participants
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort C: KNpCb (Regimen 2) / KAC
n=10 Participants
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
|
5 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 9 months (at the time of definitive surgery)Population: The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
pCR rate (ypT0 ypN0; no invasive or noninvasive residual in breast or nodes) was defined as the rate of absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by American Joint Committee on Cancer (AJCC) staging criteria assessed by local pathologist at the time of definitive surgery. The percentage of participants with a pCR using the definition of ypT0 ypN0 is presented.
Outcome measures
| Measure |
Cohort D: KNpCb (Regimen 3) / KAC
n=10 Participants
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort E: KTCb (Regimen 1) / KAC
n=10 Participants
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort F: KTCb (Regimen 2) / KAC
n=10 Participants
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort A: KNp / KAC
n=10 Participants
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort B: KNpCb (Regimen 1) / KAC
n=10 Participants
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort C: KNpCb (Regimen 2) / KAC
n=10 Participants
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
|---|---|---|---|---|---|---|
|
Pathological Complete Response (pCR) Rate Using the Definition of ypT0 ypN0 (No Invasive or Noninvasive Residual in Breast or Nodes)
|
60.0 Percentage of Participants
Interval 30.4 to 85.0
|
20.0 Percentage of Participants
Interval 3.7 to 50.7
|
50.0 Percentage of Participants
Interval 22.2 to 77.8
|
50.0 Percentage of Participants
Interval 22.2 to 77.8
|
80.0 Percentage of Participants
Interval 49.3 to 96.3
|
80.0 Percentage of Participants
Interval 49.3 to 96.3
|
SECONDARY outcome
Timeframe: Up to approximately 9 months (at the time of definitive surgery)Population: The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
pCR rate (ypT0/Tis ypN0; no invasive residual in breast or nodes; noninvasive breast residuals allowed) was defined as the rate of absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by AJCC staging criteria assessed by local pathologist at the time of definitive surgery. The percentage of participants with a pCR using the alternative definition of ypT0/Tis ypN0 is presented.
Outcome measures
| Measure |
Cohort D: KNpCb (Regimen 3) / KAC
n=10 Participants
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort E: KTCb (Regimen 1) / KAC
n=10 Participants
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort F: KTCb (Regimen 2) / KAC
n=10 Participants
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort A: KNp / KAC
n=10 Participants
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort B: KNpCb (Regimen 1) / KAC
n=10 Participants
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort C: KNpCb (Regimen 2) / KAC
n=10 Participants
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
|---|---|---|---|---|---|---|
|
Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0 (No Invasive Residual in Breast or Nodes; Noninvasive Breast Residuals Allowed)
|
60.0 Percentage of Participants
Interval 30.4 to 85.0
|
30.0 Percentage of Participants
Interval 8.7 to 60.7
|
50.0 Percentage of Participants
Interval 22.2 to 77.8
|
60.0 Percentage of Participants
Interval 30.4 to 85.0
|
80.0 Percentage of Participants
Interval 49.3 to 96.3
|
80.0 Percentage of Participants
Interval 49.3 to 96.3
|
SECONDARY outcome
Timeframe: At the end of Cycle 5 following treatment with the first combination regimen (KNp, KNpCb, or KTCb) (Up to ~4 months); Each cycle was 21 days.Population: The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
ORR was defined as the percentage of participants who achieved a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters \[SOD\] of target lesions) according to RECIST 1.1 by Investigator review. Because imaging was assessed prior to surgery, a confirmation assessment of CR or PR was not obtained. Participants with missing outcome for objective response were considered non-responders. The percentage of participants who experienced a CR or PR based on RECIST 1.1 following the first combination regimen is presented.
Outcome measures
| Measure |
Cohort D: KNpCb (Regimen 3) / KAC
n=10 Participants
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort E: KTCb (Regimen 1) / KAC
n=10 Participants
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort F: KTCb (Regimen 2) / KAC
n=10 Participants
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort A: KNp / KAC
n=10 Participants
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort B: KNpCb (Regimen 1) / KAC
n=10 Participants
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort C: KNpCb (Regimen 2) / KAC
n=10 Participants
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator Review: First Combination Regimen
|
90.0 Percentage of Participants
Interval 60.6 to 99.5
|
60.0 Percentage of Participants
Interval 30.4 to 85.0
|
80.0 Percentage of Participants
Interval 49.3 to 96.3
|
60.0 Percentage of Participants
Interval 30.4 to 85.0
|
90.0 Percentage of Participants
Interval 60.6 to 99.5
|
90.0 Percentage of Participants
Interval 60.6 to 99.5
|
SECONDARY outcome
Timeframe: After completion of the second combination regimen (KAC; Cycle 9) but prior to surgery (Up to ~9 months); Each cycle was 21 days.Population: The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
ORR was defined as the percentage of participants who achieved a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters \[SOD\] of target lesions) according to RECIST 1.1 by Investigator review. Because imaging was assessed prior to surgery, a confirmation assessment of CR or PR was not obtained. Participants with missing outcome for objective response were considered non-responders. The percentage of participants who experienced a CR or PR based on RECIST 1.1 following the second combination regimen is presented.
Outcome measures
| Measure |
Cohort D: KNpCb (Regimen 3) / KAC
n=10 Participants
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort E: KTCb (Regimen 1) / KAC
n=10 Participants
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort F: KTCb (Regimen 2) / KAC
n=10 Participants
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort A: KNp / KAC
n=10 Participants
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort B: KNpCb (Regimen 1) / KAC
n=10 Participants
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort C: KNpCb (Regimen 2) / KAC
n=10 Participants
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator Review: Second Combination Regimen
|
90.0 Percentage of Participants
Interval 60.6 to 99.5
|
70.0 Percentage of Participants
Interval 39.3 to 91.3
|
90.0 Percentage of Participants
Interval 60.6 to 99.5
|
80.0 Percentage of Participants
Interval 49.3 to 96.3
|
100 Percentage of Participants
Interval 74.1 to 100.0
|
100 Percentage of Participants
Interval 74.1 to 100.0
|
SECONDARY outcome
Timeframe: Month 6Population: The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
EFS was defined as the time from the first dose date of study treatment to any of the following events: progression of disease that precludes definitive surgery, disease recurrence (for participants with complete surgical resection), progression (for participants with incomplete surgical resection), or death due to any cause. Participants without documented events were censored at the date of the last disease status assessment. The Kaplan-Meier estimates of the percentage of participants who were event free at Month 6 are presented (through Final Analysis cut-off of 18-Nov-2019).
Outcome measures
| Measure |
Cohort D: KNpCb (Regimen 3) / KAC
n=10 Participants
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort E: KTCb (Regimen 1) / KAC
n=10 Participants
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort F: KTCb (Regimen 2) / KAC
n=10 Participants
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort A: KNp / KAC
n=10 Participants
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort B: KNpCb (Regimen 1) / KAC
n=10 Participants
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort C: KNpCb (Regimen 2) / KAC
n=10 Participants
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
|---|---|---|---|---|---|---|
|
Event-Free Survival (EFS) Rate at Month 6
|
90.0 Percentage of Participants
Interval 57.9 to 98.0
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
90.0 Percentage of Participants
Interval 57.9 to 98.0
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
100.00 Percentage of Participants
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: Month 12Population: The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
EFS was defined as the time from the first dose date of study treatment to any of the following events: progression of disease that precludes definitive surgery, disease recurrence (for participants with complete surgical resection), progression (for participants with incomplete surgical resection), or death due to any cause. Participants without documented events were censored at the date of the last disease status assessment. The Kaplan-Meier estimates of the percentage of participants who were event free at Month 12 are presented (through Final Analysis cut-off of 18-Nov-2019).
Outcome measures
| Measure |
Cohort D: KNpCb (Regimen 3) / KAC
n=10 Participants
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort E: KTCb (Regimen 1) / KAC
n=10 Participants
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort F: KTCb (Regimen 2) / KAC
n=10 Participants
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort A: KNp / KAC
n=10 Participants
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort B: KNpCb (Regimen 1) / KAC
n=10 Participants
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort C: KNpCb (Regimen 2) / KAC
n=10 Participants
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
|---|---|---|---|---|---|---|
|
Event-Free Survival (EFS) Rate at Month 12
|
90.0 Percentage of Participants
Interval 57.9 to 98.0
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
80.0 Percentage of Participants
Interval 48.9 to 93.3
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: Month 24Population: The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
EFS was defined as the time from the first dose date of study treatment to any of the following events: progression of disease that precludes definitive surgery, disease recurrence (for participants with complete surgical resection), progression (for participants with incomplete surgical resection), or death due to any cause. Participants without documented events were censored at the date of the last disease status assessment. The Kaplan-Meier estimates of the percentage of participants who were event free at Month 24 are presented (through Final Analysis cut-off of 18-Nov-2019).
Outcome measures
| Measure |
Cohort D: KNpCb (Regimen 3) / KAC
n=10 Participants
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort E: KTCb (Regimen 1) / KAC
n=10 Participants
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort F: KTCb (Regimen 2) / KAC
n=10 Participants
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort A: KNp / KAC
n=10 Participants
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort B: KNpCb (Regimen 1) / KAC
n=10 Participants
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort C: KNpCb (Regimen 2) / KAC
n=10 Participants
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
|---|---|---|---|---|---|---|
|
Event-Free Survival (EFS) Rate at Month 24
|
90.0 Percentage of Participants
Interval 57.9 to 98.0
|
90.0 Percentage of Participants
Interval 57.9 to 98.0
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
60.0 Percentage of Participants
Interval 30.9 to 80.1
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: Month 6Population: The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
OS was defined as the time from the first dose date of study treatment to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The Kaplan-Meier estimates of the percentage of participants who were surviving at Month 6 are presented (through Final Analysis cut-off of 18-Nov-2019).
Outcome measures
| Measure |
Cohort D: KNpCb (Regimen 3) / KAC
n=10 Participants
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort E: KTCb (Regimen 1) / KAC
n=10 Participants
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort F: KTCb (Regimen 2) / KAC
n=10 Participants
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort A: KNp / KAC
n=10 Participants
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort B: KNpCb (Regimen 1) / KAC
n=10 Participants
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort C: KNpCb (Regimen 2) / KAC
n=10 Participants
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS) Rate at Month 6
|
90.0 Percentage of Participants
Interval 57.9 to 98.0
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: Month 12Population: The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
OS was defined as the time from the first dose date of study treatment to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The Kaplan-Meier estimates of the percentage of participants who were surviving at Month 12 are presented (through Final Analysis cut-off of 18-Nov-2019).
Outcome measures
| Measure |
Cohort D: KNpCb (Regimen 3) / KAC
n=10 Participants
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort E: KTCb (Regimen 1) / KAC
n=10 Participants
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort F: KTCb (Regimen 2) / KAC
n=10 Participants
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort A: KNp / KAC
n=10 Participants
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort B: KNpCb (Regimen 1) / KAC
n=10 Participants
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort C: KNpCb (Regimen 2) / KAC
n=10 Participants
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS) Rate at Month 12
|
90.0 Percentage of Participants
Interval 57.9 to 98.0
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
80.0 Percentage of Participants
Interval 48.9 to 93.3
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: Month 24Population: The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
OS was defined as the time from the first dose date of study treatment to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The Kaplan-Meier estimates of the percentage of participants who were surviving at Month 24 are presented (through Final Analysis cut-off of 18-Nov-2019).
Outcome measures
| Measure |
Cohort D: KNpCb (Regimen 3) / KAC
n=10 Participants
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort E: KTCb (Regimen 1) / KAC
n=10 Participants
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort F: KTCb (Regimen 2) / KAC
n=10 Participants
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort A: KNp / KAC
n=10 Participants
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort B: KNpCb (Regimen 1) / KAC
n=10 Participants
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort C: KNpCb (Regimen 2) / KAC
n=10 Participants
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS) Rate at Month 24
|
90.0 Percentage of Participants
Interval 57.9 to 98.0
|
90.0 Percentage of Participants
Interval 57.9 to 98.0
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
70.0 Percentage of Participants
Interval 39.6 to 87.2
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
100.0 Percentage of Participants
Interval 100.0 to 100.0
|
Adverse Events
Cohort A: KNp / KAC
Serious events: 5 serious events
Other events: 10 other events
Deaths: 4 deaths
Cohort B: KNpCb (Regimen 1) / KAC
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort C: KNpCb (Regimen 2) / KAC
Serious events: 8 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort D: KNpCb (Regimen 3) / KAC
Serious events: 7 serious events
Other events: 10 other events
Deaths: 1 deaths
Cohort E: KTCb (Regimen 1) / KAC
Serious events: 3 serious events
Other events: 10 other events
Deaths: 1 deaths
Cohort F: KTCb (Regimen 2) / KAC
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A: KNp / KAC
n=10 participants at risk
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort B: KNpCb (Regimen 1) / KAC
n=10 participants at risk
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort C: KNpCb (Regimen 2) / KAC
n=10 participants at risk
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort D: KNpCb (Regimen 3) / KAC
n=10 participants at risk
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort E: KTCb (Regimen 1) / KAC
n=10 participants at risk
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort F: KTCb (Regimen 2) / KAC
n=10 participants at risk
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 6 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Influenza
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Septic shock
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Autonomic neuropathy
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Brachial plexopathy
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Subacute cutaneous lupus erythematosus
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
Other adverse events
| Measure |
Cohort A: KNp / KAC
n=10 participants at risk
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort B: KNpCb (Regimen 1) / KAC
n=10 participants at risk
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort C: KNpCb (Regimen 2) / KAC
n=10 participants at risk
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort D: KNpCb (Regimen 3) / KAC
n=10 participants at risk
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m\^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort E: KTCb (Regimen 1) / KAC
n=10 participants at risk
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
Cohort F: KTCb (Regimen 2) / KAC
n=10 participants at risk
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m\^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m\^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Oral candidiasis
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Pulpitis dental
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Rhinitis
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
90.0%
9/10 • Number of events 14 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
70.0%
7/10 • Number of events 14 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
60.0%
6/10 • Number of events 7 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
70.0%
7/10 • Number of events 10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
60.0%
6/10 • Number of events 13 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 6 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
40.0%
4/10 • Number of events 10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
80.0%
8/10 • Number of events 24 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
70.0%
7/10 • Number of events 30 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
80.0%
8/10 • Number of events 25 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 5 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
60.0%
6/10 • Number of events 7 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
70.0%
7/10 • Number of events 14 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 7 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Cardiac disorders
Cardiovascular disorder
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Cardiac disorders
Pericardial effusion
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Ear and labyrinth disorders
Vertigo
|
20.0%
2/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Endocrine disorders
Thyroiditis
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Eye disorders
Dry eye
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Gastritis
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Eye disorders
Eye disorder
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Eye disorders
Lacrimation increased
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Eye disorders
Visual impairment
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • Number of events 5 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 7 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
50.0%
5/10 • Number of events 7 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 7 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 9 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 7 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
50.0%
5/10 • Number of events 7 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 6 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
40.0%
4/10 • Number of events 6 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 6 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 5 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
60.0%
6/10 • Number of events 17 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
80.0%
8/10 • Number of events 22 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
100.0%
10/10 • Number of events 23 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
50.0%
5/10 • Number of events 13 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
80.0%
8/10 • Number of events 22 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
60.0%
6/10 • Number of events 9 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
30.0%
3/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 5 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
4/10 • Number of events 9 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 5 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
50.0%
5/10 • Number of events 11 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 9 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Asthenia
|
30.0%
3/10 • Number of events 9 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
60.0%
6/10 • Number of events 8 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 8 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 5 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Chest discomfort
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Chest pain
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Chills
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Facial pain
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Fatigue
|
50.0%
5/10 • Number of events 7 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 5 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
50.0%
5/10 • Number of events 12 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 6 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
60.0%
6/10 • Number of events 6 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
60.0%
6/10 • Number of events 9 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Influenza like illness
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Injection site induration
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Injection site pain
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Malaise
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Mucosal dryness
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Mucosal inflammation
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
60.0%
6/10 • Number of events 8 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Oedema
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Oedema peripheral
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Pain
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Peripheral swelling
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Puncture site swelling
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Pyrexia
|
30.0%
3/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Sensation of foreign body
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Temperature regulation disorder
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Immune system disorders
Food allergy
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Candida infection
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Cellulitis
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Conjunctivitis
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
External ear cellulitis
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Vulvovaginitis
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Wound infection
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
30.0%
3/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
30.0%
3/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Hepatic enzyme decreased
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Neutrophil count decreased
|
20.0%
2/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 5 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 5 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
50.0%
5/10 • Number of events 11 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Platelet count decreased
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Respirovirus test positive
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Vitamin D increased
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Weight decreased
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
White blood cell count
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
50.0%
5/10 • Number of events 6 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 8 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
50.0%
5/10 • Number of events 7 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 8 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Joint noise
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
2/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 7 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 6 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oligodendroglioma
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Dysgeusia
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Headache
|
40.0%
4/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
50.0%
5/10 • Number of events 8 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Neuropathy peripheral
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
5/10 • Number of events 5 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 6 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Petit mal epilepsy
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Syncope
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Psychiatric disorders
Confusional state
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Psychiatric disorders
Libido increased
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Psychiatric disorders
Personality change
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Reproductive system and breast disorders
Breast pain
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Reproductive system and breast disorders
Pruritus genital
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Reproductive system and breast disorders
Vulval ulceration
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
3/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
70.0%
7/10 • Number of events 7 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
50.0%
5/10 • Number of events 5 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
50.0%
5/10 • Number of events 5 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
50.0%
5/10 • Number of events 5 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 4 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
10.0%
1/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.0%
3/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
5/10 • Number of events 6 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 6 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
50.0%
5/10 • Number of events 5 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
4/10 • Number of events 5 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
30.0%
3/10 • Number of events 3 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
2/10 • Number of events 2 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Vascular disorders
Embolism
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Vascular disorders
Flushing
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Vascular disorders
Hot flush
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Vascular disorders
Vein disorder
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Physical deconditioning
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle discomfort
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
10.0%
1/10 • Number of events 1 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/10 • Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
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. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER