Trial Outcomes & Findings for Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859) (NCT NCT03675737)
NCT ID: NCT03675737
Last Updated: 2026-02-27
Results Overview
OS was defined as the time from randomization 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. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1579 participants
Primary outcome timeframe
Up to 45.9 months
Results posted on
2026-02-27
Participant Flow
Participant milestones
| Measure |
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).
Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Chemotherapy (FP or CAPOX Regimen)
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
|
|---|---|---|
|
Overall Study
STARTED
|
790
|
789
|
|
Overall Study
Treated
|
785
|
787
|
|
Overall Study
Received Pembrolizumab Second Course
|
12
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
790
|
789
|
Reasons for withdrawal
| Measure |
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).
Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Chemotherapy (FP or CAPOX Regimen)
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
|
|---|---|---|
|
Overall Study
Death
|
685
|
726
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
15
|
13
|
|
Overall Study
Sponsor Decision
|
88
|
46
|
Baseline Characteristics
Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
n=790 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).
Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Chemotherapy (FP or CAPOX Regimen)
n=789 Participants
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
|
Total
n=1579 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.3 Years
STANDARD_DEVIATION 11.9 • n=24 Participants
|
60.0 Years
STANDARD_DEVIATION 11.8 • n=20 Participants
|
59.6 Years
STANDARD_DEVIATION 11.8 • n=40 Participants
|
|
Sex: Female, Male
Female
|
263 Participants
n=24 Participants
|
245 Participants
n=20 Participants
|
508 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
527 Participants
n=24 Participants
|
544 Participants
n=20 Participants
|
1071 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
175 Participants
n=24 Participants
|
157 Participants
n=20 Participants
|
332 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
590 Participants
n=24 Participants
|
615 Participants
n=20 Participants
|
1205 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=24 Participants
|
17 Participants
n=20 Participants
|
42 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
31 Participants
n=24 Participants
|
36 Participants
n=20 Participants
|
67 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
270 Participants
n=24 Participants
|
269 Participants
n=20 Participants
|
539 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=24 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=24 Participants
|
9 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
426 Participants
n=24 Participants
|
435 Participants
n=20 Participants
|
861 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
43 Participants
n=24 Participants
|
30 Participants
n=20 Participants
|
73 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=24 Participants
|
8 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) <1 and CPS ≥1 Status
CPS ≥1
|
618 Participants
n=24 Participants
|
617 Participants
n=20 Participants
|
1235 Participants
n=40 Participants
|
|
Chemotherapy Regimen
CAPOX Regimen
|
682 Participants
n=24 Participants
|
681 Participants
n=20 Participants
|
1363 Participants
n=40 Participants
|
|
Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) <1 and CPS ≥1 Status
CPS <1
|
172 Participants
n=24 Participants
|
172 Participants
n=20 Participants
|
344 Participants
n=40 Participants
|
|
Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 Status
CPS ≥10
|
280 Participants
n=24 Participants
|
273 Participants
n=20 Participants
|
553 Participants
n=40 Participants
|
|
Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 Status
CPS <10
|
508 Participants
n=24 Participants
|
516 Participants
n=20 Participants
|
1024 Participants
n=40 Participants
|
|
Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 Status
Unknown
|
2 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Chemotherapy Regimen
FP Regimen
|
108 Participants
n=24 Participants
|
108 Participants
n=20 Participants
|
216 Participants
n=40 Participants
|
|
Geographic Region
Western Europe/Israel/North America/Australia
|
201 Participants
n=24 Participants
|
202 Participants
n=20 Participants
|
403 Participants
n=40 Participants
|
|
Geographic Region
Asia
|
263 Participants
n=24 Participants
|
262 Participants
n=20 Participants
|
525 Participants
n=40 Participants
|
|
Geographic Region
Rest of World
|
326 Participants
n=24 Participants
|
325 Participants
n=20 Participants
|
651 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Up to 45.9 monthsPopulation: The analysis population included all randomized participants.
OS was defined as the time from randomization 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. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.
Outcome measures
| Measure |
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
n=790 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).
Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Chemotherapy (FP or CAPOX Regimen)
n=789 Participants
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
|
|---|---|---|
|
Overall Survival (OS) in All Participants
|
12.9 Months
Interval 11.9 to 14.0
|
11.5 Months
Interval 10.6 to 12.1
|
PRIMARY outcome
Timeframe: Up to 45.9 monthsPopulation: The analysis population included randomized participants with a PD-L1 CPS of ≥1.
OS was defined as the time from randomization 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. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.
Outcome measures
| Measure |
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
n=618 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).
Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Chemotherapy (FP or CAPOX Regimen)
n=617 Participants
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
|
|---|---|---|
|
Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
|
13.0 Months
Interval 11.6 to 14.2
|
11.4 Months
Interval 10.5 to 12.0
|
PRIMARY outcome
Timeframe: Up to 45.9 monthsPopulation: The analysis population included randomized participants with a PD-L1 CPS of ≥10.
OS was defined as the time from randomization 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. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.
Outcome measures
| Measure |
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
n=279 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).
Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Chemotherapy (FP or CAPOX Regimen)
n=272 Participants
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
|
|---|---|---|
|
Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
|
15.7 Months
Interval 13.8 to 19.3
|
11.8 Months
Interval 10.3 to 12.7
|
SECONDARY outcome
Timeframe: Up to 49.5 monthsPopulation: The analysis population included all randomized participants.
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.
Outcome measures
| Measure |
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
n=790 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).
Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Chemotherapy (FP or CAPOX Regimen)
n=789 Participants
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
|
|---|---|---|
|
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants
|
6.9 Months
Interval 6.3 to 7.2
|
5.6 Months
Interval 5.5 to 5.7
|
SECONDARY outcome
Timeframe: Up to 49.5 monthsPopulation: The analysis population included randomized participants with a PD-L1 CPS ≥1.
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.
Outcome measures
| Measure |
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
n=618 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).
Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Chemotherapy (FP or CAPOX Regimen)
n=617 Participants
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
|
|---|---|---|
|
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
|
6.9 Months
Interval 6.0 to 7.2
|
5.6 Months
Interval 5.4 to 5.7
|
SECONDARY outcome
Timeframe: Up to 49.5 monthsPopulation: The analysis population included randomized participants with a PD-L1 CPS ≥10.
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.
Outcome measures
| Measure |
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
n=279 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).
Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Chemotherapy (FP or CAPOX Regimen)
n=272 Participants
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
|
|---|---|---|
|
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
|
8.1 Months
Interval 6.8 to 8.5
|
5.6 Months
Interval 5.4 to 6.7
|
SECONDARY outcome
Timeframe: Up to 49.5 monthsPopulation: The analysis population included all randomized participants.
ORR was defined as the percentage of the participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 as assessed by BICR.
Outcome measures
| Measure |
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
n=790 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).
Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Chemotherapy (FP or CAPOX Regimen)
n=789 Participants
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
|
|---|---|---|
|
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants
|
51.3 Percentage of Participants
Interval 47.7 to 54.8
|
42.0 Percentage of Participants
Interval 38.5 to 45.5
|
SECONDARY outcome
Timeframe: Up to 49.5 monthsPopulation: The analysis population included randomized participants with a PD-L1 CPS ≥1.
ORR was defined as the percentage of the participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 as assessed by BICR.
Outcome measures
| Measure |
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
n=618 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).
Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Chemotherapy (FP or CAPOX Regimen)
n=617 Participants
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
|
|---|---|---|
|
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
|
52.1 Percentage of Participants
Interval 48.1 to 56.1
|
42.6 Percentage of Participants
Interval 38.7 to 46.6
|
SECONDARY outcome
Timeframe: Up to 49.5 monthsPopulation: The analysis population included randomized participants with a PD-L1 CPS ≥10.
ORR was defined as the percentage of the participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 as assessed by BICR.
Outcome measures
| Measure |
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
n=279 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).
Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Chemotherapy (FP or CAPOX Regimen)
n=272 Participants
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
|
|---|---|---|
|
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
|
60.6 Percentage of Participants
Interval 54.6 to 66.3
|
43.0 Percentage of Participants
Interval 37.1 to 49.1
|
SECONDARY outcome
Timeframe: Up to 49.5 monthsPopulation: The analysis population included all randomized participants who experienced a confirmed CR or PR.
DOR was defined as the time from first documented evidence of a confirmed Complete Response (CR) or Partial Response (PR) until progressive disease (PD) or death, whichever occurred first. Per RECIST 1.1 as assessed by BICR, CR was the disappearance of all target lesions and PR was ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. PD was defined as ≥20% increase in the SOD of target lesions according to RECIST 1.1. In addition to the relative increase of 20%, the SOD must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. DOR for participants who had not progressed or died at the time of analysis was censored at the date of the last tumor assessment. DOR was estimated using the product-limit (Kaplan-Meier) method for censored data.
Outcome measures
| Measure |
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
n=405 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).
Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Chemotherapy (FP or CAPOX Regimen)
n=331 Participants
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
|
|---|---|---|
|
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants
|
8.0 Months
Interval 7.0 to 9.7
|
5.7 Months
Interval 5.5 to 6.9
|
SECONDARY outcome
Timeframe: Up to 49.5 monthsPopulation: The analysis population included randomized participants, with a PD-L1 CPS ≥1, who experienced a confirmed CR or PR.
DOR was defined as the time from first documented evidence of a confirmed Complete Response (CR) or Partial Response (PR) until progressive disease (PD) or death, whichever occurred first. Per RECIST 1.1 as assessed by BICR, CR was the disappearance of all target lesions and PR was ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. PD was defined as ≥20% increase in the SOD of target lesions according to RECIST 1.1. In addition to the relative increase of 20%, the SOD must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. DOR for participants who had not progressed or died at the time of analysis was censored at the date of the last tumor assessment. DOR was estimated using the product-limit (Kaplan-Meier) method for censored data.
Outcome measures
| Measure |
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
n=322 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).
Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Chemotherapy (FP or CAPOX Regimen)
n=263 Participants
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
|
|---|---|---|
|
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
|
8.3 Months
Interval 7.0 to 10.9
|
5.6 Months
Interval 5.4 to 6.9
|
SECONDARY outcome
Timeframe: Up to 49.5 monthsPopulation: The analysis population included randomized participants, with a PD-L1 CPS ≥10, who experienced a confirmed CR or PR.
DOR was defined as the time from first documented evidence of a confirmed Complete Response (CR) or Partial Response (PR) until progressive disease (PD) or death, whichever occurred first. Per RECIST 1.1 as assessed by BICR, CR was the disappearance of all target lesions and PR was ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. PD was defined as ≥20% increase in the SOD of target lesions according to RECIST 1.1. In addition to the relative increase of 20%, the SOD must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. DOR for participants who had not progressed or died at the time of analysis was censored at the date of the last tumor assessment. DOR was estimated using the product-limit (Kaplan-Meier) method for censored data.
Outcome measures
| Measure |
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
n=169 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).
Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Chemotherapy (FP or CAPOX Regimen)
n=117 Participants
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
|
|---|---|---|
|
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
|
10.9 Months
Interval 8.0 to 13.8
|
5.8 Months
Interval 5.3 to 7.0
|
SECONDARY outcome
Timeframe: Up to approximately 49.3 monthsPopulation: The analysis population included all participants who received at least one dose of study treatment.
An AE was defined as any untoward medical occurrence, in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE is presented.
Outcome measures
| Measure |
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
n=785 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).
Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Chemotherapy (FP or CAPOX Regimen)
n=787 Participants
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
|
|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
776 Participants
|
771 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 46.3 monthsPopulation: The analysis population included all participants who received at least one dose of study treatment.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented.
Outcome measures
| Measure |
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
n=785 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).
Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Chemotherapy (FP or CAPOX Regimen)
n=787 Participants
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
|
|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
|
267 Participants
|
206 Participants
|
Adverse Events
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
Serious events: 358 serious events
Other events: 755 other events
Deaths: 689 deaths
Placebo + Chemotherapy (FP or CAPOX Regimen)
Serious events: 317 serious events
Other events: 751 other events
Deaths: 733 deaths
Pembrolizumab Second Course
Serious events: 1 serious events
Other events: 10 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
n=785 participants at risk
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).
Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Chemotherapy (FP or CAPOX Regimen)
n=787 participants at risk
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
|
Pembrolizumab Second Course
n=12 participants at risk
Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule of 200 mg IV on Day 1 Q3W for up to 17 cycles (up to approximately 1 year).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
8/785 • Number of events 10 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
1.0%
8/787 • Number of events 10 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.89%
7/787 • Number of events 7 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.38%
3/785 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.51%
4/787 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.64%
5/787 • Number of events 5 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Arrhythmia
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Atrial fibrillation
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.38%
3/787 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Atrial flutter
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Bradycardia
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Cardiac arrest
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Cardiac failure
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Cardiac tamponade
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Coronary artery disease
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Myocardial infarction
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Pericardial effusion
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Tachycardia
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Ear and labyrinth disorders
Vertigo
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.51%
4/785 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Endocrine disorders
Hypopituitarism
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Eye disorders
Cataract
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Eye disorders
Diabetic retinopathy
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Eye disorders
Retinal artery occlusion
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
12/785 • Number of events 12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
1.1%
9/787 • Number of events 9 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.51%
4/787 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Ascites
|
0.64%
5/785 • Number of events 6 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
1.1%
9/787 • Number of events 11 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Colitis
|
2.0%
16/785 • Number of events 16 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.51%
4/787 • Number of events 5 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Constipation
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.64%
5/787 • Number of events 6 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
32/785 • Number of events 35 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
3.2%
25/787 • Number of events 26 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Dysphagia
|
1.1%
9/785 • Number of events 9 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
1.9%
15/787 • Number of events 15 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Enteritis
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.51%
4/787 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Faecaloma
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.64%
5/785 • Number of events 5 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.89%
7/787 • Number of events 7 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.51%
4/787 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Gastritis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.38%
3/787 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
9/785 • Number of events 12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
1.0%
8/787 • Number of events 12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Haematemesis
|
0.25%
2/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Ileus
|
0.89%
7/785 • Number of events 9 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.64%
5/787 • Number of events 6 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.0%
8/785 • Number of events 8 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.76%
6/787 • Number of events 6 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Malignant ascites
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
14/785 • Number of events 14 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
1.4%
11/787 • Number of events 12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
1.1%
9/787 • Number of events 9 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Oral pain
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Proctalgia
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.51%
4/785 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Stomatitis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Terminal ileitis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.1%
9/785 • Number of events 9 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
1.0%
8/787 • Number of events 8 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
19/785 • Number of events 20 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
2.9%
23/787 • Number of events 24 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Asthenia
|
0.51%
4/785 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.64%
5/787 • Number of events 5 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Chest discomfort
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Chest pain
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Complication associated with device
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Death
|
1.4%
11/785 • Number of events 11 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.51%
4/787 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Face oedema
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Fatigue
|
0.51%
4/785 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.76%
6/787 • Number of events 6 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
General physical health deterioration
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Hyperthermia
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Injection site discolouration
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Localised oedema
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Malaise
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Mucosal inflammation
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.64%
5/787 • Number of events 5 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Oedema peripheral
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Pyrexia
|
1.5%
12/785 • Number of events 16 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
1.1%
9/787 • Number of events 14 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Sudden death
|
0.51%
4/785 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Hepatobiliary disorders
Biliary fistula
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.51%
4/785 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Hepatobiliary disorders
Cholangitis
|
0.38%
3/785 • Number of events 12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.38%
3/787 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Hepatobiliary disorders
Hepatitis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Hepatobiliary disorders
Jaundice
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Hepatobiliary disorders
Vanishing bile duct syndrome
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Immune system disorders
Anaphylactic reaction
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Immune system disorders
Drug hypersensitivity
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Appendicitis perforated
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Biliary tract infection
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Bronchitis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
COVID-19
|
0.76%
6/785 • Number of events 6 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.51%
4/787 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.64%
5/785 • Number of events 5 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.38%
3/787 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Chlamydial infection
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Cholangitis infective
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Device related infection
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Diverticulitis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Endocarditis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Enterocolitis infectious
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Epiglottitis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Erysipelas
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Gastroenteritis
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Gastroenteritis viral
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Infection
|
0.51%
4/785 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Influenza
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Liver abscess
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Lymph node abscess
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Pleural infection
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Pneumonia
|
3.8%
30/785 • Number of events 30 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
1.8%
14/787 • Number of events 14 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Pyelonephritis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Sepsis
|
0.89%
7/785 • Number of events 8 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.89%
7/787 • Number of events 8 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Septic encephalopathy
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Septic shock
|
0.51%
4/785 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.64%
5/787 • Number of events 5 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Sinusitis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Skin infection
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Streptococcal infection
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Tinea manuum
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Tinea pedis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Urinary tract infection
|
0.38%
3/785 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Urosepsis
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Wound infection
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic stenosis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.64%
5/785 • Number of events 5 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Injury, poisoning and procedural complications
Peripheral nerve injury
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Injury, poisoning and procedural complications
Unintentional medical device removal
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Alanine aminotransferase increased
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Aspartate aminotransferase increased
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Blood bilirubin increased
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Blood creatinine increased
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Ejection fraction decreased
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
False positive investigation result
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Lipase increased
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Neutrophil count decreased
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Platelet count decreased
|
0.89%
7/785 • Number of events 7 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.89%
7/787 • Number of events 9 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Transaminases increased
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Weight decreased
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
White blood cell count decreased
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.1%
9/785 • Number of events 9 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
1.3%
10/787 • Number of events 11 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.64%
5/785 • Number of events 5 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.51%
4/787 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.0%
8/785 • Number of events 8 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.76%
6/787 • Number of events 7 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.51%
4/785 • Number of events 7 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.38%
3/787 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Musculoskeletal and connective tissue disorders
Paraneoplastic dermatomyositis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.38%
3/787 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Amnesia
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Cerebral infarction
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.51%
4/787 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Dizziness
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Headache
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Myasthenia gravis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Neuralgia
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Optic neuritis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Paraneoplastic encephalomyelitis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Seizure
|
0.13%
1/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Syncope
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.51%
4/787 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Product Issues
Device breakage
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Product Issues
Device dislocation
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Product Issues
Device occlusion
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Product Issues
Stent malfunction
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
12/785 • Number of events 13 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
1.4%
11/787 • Number of events 11 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Renal and urinary disorders
Haematuria
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.38%
3/787 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Renal and urinary disorders
Nephritis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Renal and urinary disorders
Renal failure
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal oedema
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.0%
8/785 • Number of events 8 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.0%
8/785 • Number of events 8 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.9%
15/785 • Number of events 15 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.76%
6/787 • Number of events 6 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.38%
3/787 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Vascular disorders
Aortic dissection
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Vascular disorders
Aortic thrombosis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Vascular disorders
Arteriosclerosis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Vascular disorders
Deep vein thrombosis
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Vascular disorders
Embolism
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Vascular disorders
Hypertension
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Vascular disorders
Hypotension
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.38%
3/787 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Vascular disorders
Jugular vein embolism
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Vascular disorders
Peripheral embolism
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Vascular disorders
Peripheral ischaemia
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
Other adverse events
| Measure |
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
n=785 participants at risk
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).
Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
|
Placebo + Chemotherapy (FP or CAPOX Regimen)
n=787 participants at risk
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
|
Pembrolizumab Second Course
n=12 participants at risk
Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule of 200 mg IV on Day 1 Q3W for up to 17 cycles (up to approximately 1 year).
|
|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
2.5%
20/785 • Number of events 23 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
1.9%
15/787 • Number of events 16 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Endocrine disorders
Hyperthyroidism
|
5.5%
43/785 • Number of events 44 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
1.7%
13/787 • Number of events 15 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.6%
28/785 • Number of events 38 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
2.0%
16/787 • Number of events 25 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
25.0%
3/12 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.6%
146/785 • Number of events 309 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
17.9%
141/787 • Number of events 294 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
16.7%
2/12 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.1%
95/785 • Number of events 147 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
10.5%
83/787 • Number of events 137 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
16.7%
2/12 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Blood and lymphatic system disorders
Anaemia
|
41.4%
325/785 • Number of events 512 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
35.8%
282/787 • Number of events 413 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
25.0%
3/12 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.0%
47/785 • Number of events 76 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
5.3%
42/787 • Number of events 79 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
16.7%
2/12 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Endocrine disorders
Hypothyroidism
|
15.4%
121/785 • Number of events 139 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
4.3%
34/787 • Number of events 40 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Eye disorders
Eye swelling
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
39/785 • Number of events 43 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
5.1%
40/787 • Number of events 42 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.6%
130/785 • Number of events 165 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
14.1%
111/787 • Number of events 137 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.0%
63/785 • Number of events 72 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
7.9%
62/787 • Number of events 68 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Constipation
|
21.5%
169/785 • Number of events 207 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
20.5%
161/787 • Number of events 209 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Diarrhoea
|
32.5%
255/785 • Number of events 443 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
30.2%
238/787 • Number of events 357 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
16.7%
2/12 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
48/785 • Number of events 52 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
5.0%
39/787 • Number of events 45 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Dysphagia
|
6.1%
48/785 • Number of events 50 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
4.4%
35/787 • Number of events 39 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Nausea
|
45.7%
359/785 • Number of events 626 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
45.6%
359/787 • Number of events 612 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.25%
2/787 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Stomatitis
|
7.1%
56/785 • Number of events 72 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
6.1%
48/787 • Number of events 53 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Vomiting
|
32.1%
252/785 • Number of events 423 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
24.4%
192/787 • Number of events 312 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Gastrointestinal disorders
Vomiting projectile
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Asthenia
|
15.9%
125/785 • Number of events 196 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
15.1%
119/787 • Number of events 164 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
25.0%
3/12 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Fatigue
|
24.8%
195/785 • Number of events 255 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
24.3%
191/787 • Number of events 262 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Mucosal inflammation
|
6.2%
49/785 • Number of events 64 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
4.8%
38/787 • Number of events 50 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Oedema peripheral
|
7.5%
59/785 • Number of events 73 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
7.0%
55/787 • Number of events 61 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
General disorders
Pyrexia
|
11.0%
86/785 • Number of events 132 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
6.5%
51/787 • Number of events 63 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Immune system disorders
Drug hypersensitivity
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.89%
7/787 • Number of events 12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Abscess oral
|
0.00%
0/785 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Enterocolitis infectious
|
0.25%
2/785 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
12/785 • Number of events 14 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
1.5%
12/787 • Number of events 12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Oral fungal infection
|
0.38%
3/785 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.13%
1/787 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Infections and infestations
Periodontitis
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.1%
24/785 • Number of events 31 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
2.9%
23/787 • Number of events 28 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Alanine aminotransferase increased
|
16.9%
133/785 • Number of events 179 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
12.2%
96/787 • Number of events 124 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Aspartate aminotransferase increased
|
23.3%
183/785 • Number of events 287 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
17.7%
139/787 • Number of events 194 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.4%
82/785 • Number of events 103 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.6%
68/787 • Number of events 78 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Blood bilirubin increased
|
13.8%
108/785 • Number of events 195 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
9.0%
71/787 • Number of events 133 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Blood creatinine increased
|
6.0%
47/785 • Number of events 62 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
5.1%
40/787 • Number of events 46 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Lipase increased
|
1.1%
9/785 • Number of events 9 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.51%
4/787 • Number of events 4 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Neutrophil count decreased
|
25.4%
199/785 • Number of events 554 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
22.2%
175/787 • Number of events 509 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Platelet count decreased
|
26.4%
207/785 • Number of events 424 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
23.8%
187/787 • Number of events 319 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
16.7%
2/12 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
Weight decreased
|
20.1%
158/785 • Number of events 178 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
18.7%
147/787 • Number of events 161 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Investigations
White blood cell count decreased
|
13.8%
108/785 • Number of events 336 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
11.8%
93/787 • Number of events 292 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.9%
227/785 • Number of events 302 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
27.6%
217/787 • Number of events 293 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.0%
63/785 • Number of events 110 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
5.5%
43/787 • Number of events 54 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
18.6%
146/785 • Number of events 213 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
13.3%
105/787 • Number of events 152 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.2%
49/785 • Number of events 72 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
5.8%
46/787 • Number of events 52 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.8%
116/785 • Number of events 162 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
10.7%
84/787 • Number of events 113 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 2 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.0%
55/785 • Number of events 68 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
5.0%
39/787 • Number of events 48 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.3%
73/785 • Number of events 90 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
7.2%
57/787 • Number of events 68 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.4%
50/785 • Number of events 52 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
5.7%
45/787 • Number of events 45 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/787 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Dizziness
|
6.6%
52/785 • Number of events 58 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
4.8%
38/787 • Number of events 44 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Dysgeusia
|
6.1%
48/785 • Number of events 55 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
4.7%
37/787 • Number of events 44 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Neuropathy peripheral
|
20.0%
157/785 • Number of events 215 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
22.2%
175/787 • Number of events 231 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Paraesthesia
|
6.0%
47/785 • Number of events 74 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
4.1%
32/787 • Number of events 61 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
17.7%
139/785 • Number of events 189 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
17.3%
136/787 • Number of events 184 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Nervous system disorders
Tremor
|
0.13%
1/785 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.38%
3/787 • Number of events 3 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Psychiatric disorders
Anxiety
|
2.7%
21/785 • Number of events 23 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
1.5%
12/787 • Number of events 12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Psychiatric disorders
Insomnia
|
5.5%
43/785 • Number of events 47 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
6.6%
52/787 • Number of events 55 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.2%
41/785 • Number of events 44 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
3.8%
30/787 • Number of events 32 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
24.8%
195/785 • Number of events 225 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
21.9%
172/787 • Number of events 188 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
65/785 • Number of events 91 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
2.7%
21/787 • Number of events 30 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
8.3%
1/12 • Number of events 1 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.2%
72/785 • Number of events 98 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
5.0%
39/787 • Number of events 44 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
0.00%
0/12 • Up to approximately 49.3 months
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In accordance with standard editorial and ethical practice, the Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
- Publication restrictions are in place
Restriction type: OTHER