Trial Outcomes & Findings for A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer (NCT NCT05328908)
NCT ID: NCT05328908
Last Updated: 2026-08-26
Results Overview
OS is defined as the time from date of randomization to the date of death due to any cause.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
769 participants
Primary outcome timeframe
From date of randomization to the date of death due to any cause (Up to approxaimtely 38 months)
Results posted on
2026-08-26
Participant Flow
Participant milestones
| Measure |
Arm A
Relatlimab 480 mg + Nivolumab 480 mg every 4 weeks
|
Arm B
Regorafenib 160 mg daily for 21 days of a 28-day cycle or TAS-102 35 mg/m\^2 twice daily for Days 1 to 5 and Days 8 to 12 of each 28-day cycle
|
|---|---|---|
|
Pre-Treatment
STARTED
|
385
|
384
|
|
Pre-Treatment
All randomized participants except those randomized exclusively in the Chinese population
|
359
|
360
|
|
Pre-Treatment
All participants randomized exclusively in the Chinese population
|
26
|
24
|
|
Pre-Treatment
All participants randomized in both the main population and in the Chinese population
|
28
|
28
|
|
Pre-Treatment
All randomized participants - Chinese population
|
54
|
52
|
|
Pre-Treatment
COMPLETED
|
383
|
358
|
|
Pre-Treatment
NOT COMPLETED
|
2
|
26
|
|
Treatment
STARTED
|
383
|
358
|
|
Treatment
All treated participants except those treated exclusively in the Chinese population
|
357
|
335
|
|
Treatment
All participants treated exclusively in the Chinese population
|
26
|
23
|
|
Treatment
All participants treated in both the main population and in the Chinese population
|
28
|
26
|
|
Treatment
All treated participants - Chinese population
|
54
|
49
|
|
Treatment
COMPLETED
|
0
|
0
|
|
Treatment
NOT COMPLETED
|
383
|
358
|
Reasons for withdrawal
| Measure |
Arm A
Relatlimab 480 mg + Nivolumab 480 mg every 4 weeks
|
Arm B
Regorafenib 160 mg daily for 21 days of a 28-day cycle or TAS-102 35 mg/m\^2 twice daily for Days 1 to 5 and Days 8 to 12 of each 28-day cycle
|
|---|---|---|
|
Pre-Treatment
Adverse Event
|
0
|
1
|
|
Pre-Treatment
Death
|
0
|
1
|
|
Pre-Treatment
Lost to Follow-up
|
0
|
1
|
|
Pre-Treatment
Protocol Deviation
|
0
|
3
|
|
Pre-Treatment
Withdrawal by Subject
|
0
|
19
|
|
Pre-Treatment
Physician Decision
|
1
|
0
|
|
Pre-Treatment
Other reasons
|
1
|
1
|
|
Treatment
Adverse Event
|
15
|
5
|
|
Treatment
Death
|
4
|
2
|
|
Treatment
Physician Decision
|
3
|
6
|
|
Treatment
Progressive Disease
|
323
|
308
|
|
Treatment
Study Drug Toxicity
|
18
|
10
|
|
Treatment
Subject request to discontinue study treatment
|
10
|
9
|
|
Treatment
Withdrawal by Subject
|
7
|
13
|
|
Treatment
other reasons
|
3
|
5
|
Baseline Characteristics
A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Arm A
n=385 Participants
Relatlimab 480 mg + Nivolumab 480 mg every 4 weeks
|
Arm B
n=384 Participants
Regorafenib 160 mg daily for 21 days of a 28-day cycle or TAS-102 35 mg/m\^2 twice daily for Days 1 to 5 and Days 8 to 12 of each 28-day cycle
|
Total
n=769 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.7 Years
STANDARD_DEVIATION 11.2 • n=31 Participants
|
59.9 Years
STANDARD_DEVIATION 11.3 • n=49 Participants
|
59.3 Years
STANDARD_DEVIATION 11.3 • n=80 Participants
|
|
Sex: Female, Male
Female
|
176 Participants
n=31 Participants
|
164 Participants
n=49 Participants
|
340 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
209 Participants
n=31 Participants
|
220 Participants
n=49 Participants
|
429 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=31 Participants
|
18 Participants
n=49 Participants
|
32 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
331 Participants
n=31 Participants
|
323 Participants
n=49 Participants
|
654 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
40 Participants
n=31 Participants
|
43 Participants
n=49 Participants
|
83 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
129 Participants
n=31 Participants
|
128 Participants
n=49 Participants
|
257 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=31 Participants
|
6 Participants
n=49 Participants
|
13 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
212 Participants
n=31 Participants
|
212 Participants
n=49 Participants
|
424 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
37 Participants
n=31 Participants
|
36 Participants
n=49 Participants
|
73 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to the date of death due to any cause (Up to approxaimtely 38 months)Population: All randomized participants overall and participants with PD-L1 CPS ≥ 1
OS is defined as the time from date of randomization to the date of death due to any cause.
Outcome measures
| Measure |
Arm B
n=384 Participants
Regorafenib 160 mg daily for 21 days of a 28-day cycle or TAS-102 35 mg/m\^2 twice daily for Days 1 to 5 and Days 8 to 12 of each 28-day cycle
|
Arm A
n=385 Participants
Relatlimab 480 mg + Nivolumab 480 mg every 4 weeks
|
|---|---|---|
|
Overall Survival (OS)
Overall, except those randomized exclusively in the Chinese population
|
8.57 Months
Interval 7.33 to 9.79
|
7.72 Months
Interval 6.83 to 9.2
|
|
Overall Survival (OS)
Participants with PD-L1 CPS ≥ 1, except those randomized exclusively in the Chinese population
|
10.35 Months
Interval 8.77 to 11.83
|
7.46 Months
Interval 6.14 to 10.38
|
|
Overall Survival (OS)
Chinese Overall, including those randomized exclusively in the Chinese population
|
10.22 Months
Interval 7.36 to 13.31
|
6.80 Months
Interval 4.67 to 16.92
|
|
Overall Survival (OS)
Chinese Participants with PD-L1 CPS ≥ 1, including those exclusively in the Chinese population
|
10.22 Months
Interval 6.47 to 13.31
|
12.68 Months
Interval 4.96 to
Upper limit not reached due to insufficient number of participants with events based on K-M methodology
|
SECONDARY outcome
Timeframe: From randomization until the date of objectively documented response (Up to approximately 38 months)Population: All randomized participants overall and participants with PD-L1 CPS ≥ 1 (except those randomized exclusively in the Chinese population)
ORR is defined as the percent of participants with a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR). CR=Disappearance of all target lesions. PR=At least a 30% decrease in the sum of diameters of target lesions.
Outcome measures
| Measure |
Arm B
n=360 Participants
Regorafenib 160 mg daily for 21 days of a 28-day cycle or TAS-102 35 mg/m\^2 twice daily for Days 1 to 5 and Days 8 to 12 of each 28-day cycle
|
Arm A
n=359 Participants
Relatlimab 480 mg + Nivolumab 480 mg every 4 weeks
|
|---|---|---|
|
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
Overall, except those randomized exclusively in the Chinese population
|
1.7 Percent of participants
Interval 0.6 to 3.6
|
3.1 Percent of participants
Interval 1.5 to 5.4
|
|
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
Participants with PD-L1 CPS ≥ 1, except those randomized exclusively in the Chinese population
|
2.2 Percent of participants
Interval 0.6 to 5.6
|
3.8 Percent of participants
Interval 1.5 to 7.7
|
SECONDARY outcome
Timeframe: From date of randomization to the date of first documented progression or death, whichever occurs first (Up to approximately 38 months)Population: All randomized participants overall and participants with PD-L1 CPS ≥ 1 (except those randomized exclusively in the Chinese population)
PFS is defined as the time from randomization to first documented progression (PD) or death due to any cause, whichever is earlier. PD=At least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
Arm B
n=360 Participants
Regorafenib 160 mg daily for 21 days of a 28-day cycle or TAS-102 35 mg/m\^2 twice daily for Days 1 to 5 and Days 8 to 12 of each 28-day cycle
|
Arm A
n=359 Participants
Relatlimab 480 mg + Nivolumab 480 mg every 4 weeks
|
|---|---|---|
|
Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)
Overall, except those randomized exclusively in the Chinese population
|
2.10 Months
Interval 1.94 to 2.53
|
1.87 Months
Interval 1.84 to 1.87
|
|
Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)
Participants with PD-L1 CPS ≥ 1, except those randomized exclusively in the Chinese population
|
2.10 Months
Interval 1.94 to 3.48
|
1.87 Months
Interval 1.84 to 1.91
|
SECONDARY outcome
Timeframe: From date of randomization to the date of first documented progression or death, whichever occurs first (Up to approximately 38 months)Population: All responders overall and with PD-L1 CPS ≥ 1 (except those randomized exclusively in the Chinese population)
DoR is defined as the time between the date of first confirmed documented response (CR or PR) to the date of the first documented tumor progression as determined by BICR (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. CR=Disappearance of all target lesions. PR=At least a 30% decrease in the sum of diameters of target lesions. PD=At least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
Arm B
n=6 Participants
Regorafenib 160 mg daily for 21 days of a 28-day cycle or TAS-102 35 mg/m\^2 twice daily for Days 1 to 5 and Days 8 to 12 of each 28-day cycle
|
Arm A
n=11 Participants
Relatlimab 480 mg + Nivolumab 480 mg every 4 weeks
|
|---|---|---|
|
Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
Overall, except those randomized exclusively in the Chinese population
|
5.55 Months
Interval 3.5 to 18.7
|
11.10 Months
Interval 3.7 to 20.6
|
|
Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
Participants with PD-L1 CPS ≥ 1, except those randomized exclusively in the Chinese population
|
5.55 Months
Interval 3.5 to 14.8
|
8.34 Months
Interval 3.7 to 20.6
|
SECONDARY outcome
Timeframe: From first dose until 30 days post last dose (Up to 24 months)Population: All treated participants
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence at any dose that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions, results in a congenital abnormality or birth defect, or is an important medical event that may not result in death, be life-threatening, or require hospitalization, but may require medical or surgical intervention to prevent any of the outcomes listed above.
Outcome measures
| Measure |
Arm B
n=358 Participants
Regorafenib 160 mg daily for 21 days of a 28-day cycle or TAS-102 35 mg/m\^2 twice daily for Days 1 to 5 and Days 8 to 12 of each 28-day cycle
|
Arm A
n=383 Participants
Relatlimab 480 mg + Nivolumab 480 mg every 4 weeks
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
AEs leading to d/c, All treated participants except those exclusively in the Chinese population
|
31 Participants
|
37 Participants
|
|
Number of Participants With Adverse Events (AEs)
AEs leading to any drug discontinuation, All treated participants - Chinese population
|
1 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs)
AEs, All treated participants except those treated exclusively in the Chinese population
|
322 Participants
|
341 Participants
|
|
Number of Participants With Adverse Events (AEs)
AEs, All treated participants - Chinese population
|
49 Participants
|
51 Participants
|
|
Number of Participants With Adverse Events (AEs)
SAEs, All treated participants except those treated exclusively in the Chinese population
|
93 Participants
|
128 Participants
|
|
Number of Participants With Adverse Events (AEs)
SAEs, All treated participants - Chinese population
|
18 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: From first dose until 30 days post last dose (Up to 24 months)Population: All treated participants
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Arm B
n=358 Participants
Regorafenib 160 mg daily for 21 days of a 28-day cycle or TAS-102 35 mg/m\^2 twice daily for Days 1 to 5 and Days 8 to 12 of each 28-day cycle
|
Arm A
n=383 Participants
Relatlimab 480 mg + Nivolumab 480 mg every 4 weeks
|
|---|---|---|
|
Number of Participants With Select Adverse Events (AEs)
Select AEs (GI), All treated participants except those exclusively in the Chinese population
|
77 Participants
|
47 Participants
|
|
Number of Participants With Select Adverse Events (AEs)
Select AEs (Hepatic), All treated participants except those exclusively in the Chinese population
|
53 Participants
|
71 Participants
|
|
Number of Participants With Select Adverse Events (AEs)
Select AEs (Pulmonary), All treated participants except those exclusively in the Chinese population
|
0 Participants
|
3 Participants
|
|
Number of Participants With Select Adverse Events (AEs)
Select AEs (Renal), All treated participants except those exclusively in the Chinese population
|
9 Participants
|
17 Participants
|
|
Number of Participants With Select Adverse Events (AEs)
Select AEs (Skin), All treated participants except those exclusively in the Chinese population
|
75 Participants
|
52 Participants
|
|
Number of Participants With Select Adverse Events (AEs)
Hypersensitivity, All treated participants except those exclusively in the Chinese population
|
1 Participants
|
6 Participants
|
|
Number of Participants With Select Adverse Events (AEs)
Select AEs (Overall), All treated participants - Chinese population
|
32 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: From first dose until 30 days post last dose (Up to 24 months)Population: All treated participants
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Arm B
n=358 Participants
Regorafenib 160 mg daily for 21 days of a 28-day cycle or TAS-102 35 mg/m\^2 twice daily for Days 1 to 5 and Days 8 to 12 of each 28-day cycle
|
Arm A
n=383 Participants
Relatlimab 480 mg + Nivolumab 480 mg every 4 weeks
|
|---|---|---|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Pneumonitis, All treated participants except those treated exclusively in the Chinese population
|
0 Participants
|
3 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Diarrhea/Colitis, All participants except those treated exclusively in the Chinese population
|
0 Participants
|
5 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Diarrhea/Colitis, All treated participants - Chinese population
|
0 Participants
|
1 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Hepatitis, All treated participants except those exclusively in the Chinese population
|
0 Participants
|
16 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Hepatitis, All treated participants - Chinese population
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Nephritis/Renal Dysfunction, All participants except those exclusively in the Chinese population
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Nephritis/Renal Dysfunction, All treated participants - Chinese population
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Rash, All treated participants except those exclusively in the Chinese population
|
1 Participants
|
11 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Rash, All treated participants - Chinese population
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Hypersensitivity, All treated participants except those exclusively in the Chinese population
|
0 Participants
|
1 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Hypersensitivity, All treated participants - Chinese population
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Adrenal Insufficiency, All treated participants except those exclusively in the Chinese population
|
0 Participants
|
9 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Adrenal Insufficiency, All treated participants - Chinese population
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Hypothyroidism/Thyroiditis, All participants except those exclusively in the Chinese population
|
1 Participants
|
36 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Hypothyroidism/Thyroiditis, All treated participants - Chinese population
|
0 Participants
|
5 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Hypothyroidism, All treated participants except those exclusively in the Chinese population
|
1 Participants
|
29 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Thyroiditis, All treated participants - Chinese population
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Diabetes Mellitus, All treated participants except those exclusively in the Chinese population
|
0 Participants
|
1 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Diabetes Mellitus, All treated participants - Chinese population
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Hypothyroidism, All treated participants - Chinese population
|
0 Participants
|
5 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Pneumonitis, All treated participants - Chinese population
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Thyroiditis, All treated participants except those exclusively in the Chinese population
|
0 Participants
|
8 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Hyperthyroidism, All treated participants except those exclusively in the Chinese population
|
0 Participants
|
18 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Hyperthyroidism, All treated participants - Chinese population
|
0 Participants
|
3 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Hypophysitis, All treated participants except those exclusively in the Chinese population
|
0 Participants
|
4 Participants
|
|
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Hypophysitis, All treated participants - Chinese population
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose until 30 days post last dose (Up to 24 months)Population: All treated participants with laboratory measurements (except those treated exclusively in the Chinese population)
Blood samples were collected for assessment of laboratory test results. All abnormalities were graded as per CTCAE v5.0 on a scale from 1 to 4, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.
Outcome measures
| Measure |
Arm B
n=317 Participants
Regorafenib 160 mg daily for 21 days of a 28-day cycle or TAS-102 35 mg/m\^2 twice daily for Days 1 to 5 and Days 8 to 12 of each 28-day cycle
|
Arm A
n=347 Participants
Relatlimab 480 mg + Nivolumab 480 mg every 4 weeks
|
|---|---|---|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Platelet Count Grade 3
|
2 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Platelet Count Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Leukocytes Grade 3
|
45 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Leukocytes Grade 4
|
2 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Lymphocytes Grade 3
|
27 Participants
|
16 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Lymphocytes Grade 4
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Absolute Neutrophil count Grade 3
|
70 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Absolute Neutrophil count Grade 4
|
14 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Neutrophils Absolute Grade 3
|
69 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Neutrophils Absolute Grade 4
|
15 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Alkaline Phosphatase Grade 3
|
3 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Alkaline Phosphatase Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Aspartate Aminotransferase Grade 3
|
6 Participants
|
11 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Aspartate Aminotransferase Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Alanine Aminotransferase Grade 3
|
6 Participants
|
7 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Alanine Aminotransferase Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Bilirubin Grade 3
|
12 Participants
|
8 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Bilirubin Grade 4
|
0 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Creatinine Grade 3
|
1 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Creatinine Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Creatine Kinase Grade 3
|
0 Participants
|
6 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Creatine Kinase Grade 4
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Amylase Grade 3
|
0 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Amylase Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Albumin Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Albumin Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Hypernatremia Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Hypernatremia Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Hyponatremia Grade 3
|
4 Participants
|
7 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Hyponatremia Grade 4
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Hyperkalemia Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Hyperkalemia Grade 4
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Hypokalemia Grade 3
|
10 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Hypokalemia Grade 4
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Hypercalcemia Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Hypercalcemia Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Hypocalcemia Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Hypocalcemia Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Hypermagnesemia Grade 3
|
2 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Hypermagnesemia Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Hypomagnesemia Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Hypomagnesemia Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Hypoglycemia Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Hypoglycemia Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Apit (SEC) Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Apit (SEC) Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Hemoglobin grade 3
|
30 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From randomization until the first date of a definititve clincial decline from baseline in QoL scale score (Up to approximately 38 months)Population: All randomized participants overall and participants with PD-L1 CPS ≥ 1 (except those randomized exclusively in the Chinese population)
TUDD-QoL is defined as time from randomization until the first date of a definitive clinically meaningful decline from baseline in EORTC QLQ-C30 health status/QoL scale score. A definitive deterioration is defined as when all subsequent PRO assessments after a deterioration also reach or exceed the pre-defined meaningful change threshold. A decrease in score of at least 15 points from baseline will be considered to be the meaningful change threshold (MCT) for the global health status/quality-of-life and scale.
Outcome measures
| Measure |
Arm B
n=360 Participants
Regorafenib 160 mg daily for 21 days of a 28-day cycle or TAS-102 35 mg/m\^2 twice daily for Days 1 to 5 and Days 8 to 12 of each 28-day cycle
|
Arm A
n=359 Participants
Relatlimab 480 mg + Nivolumab 480 mg every 4 weeks
|
|---|---|---|
|
Time Until Definitive Deterioration - Quality of Life (TUDD-QoL)
Overall, except those randomized exclusively in the Chinese population
|
5.78 Months
Interval 4.17 to 7.16
|
4.40 Months
Interval 3.68 to 5.49
|
|
Time Until Definitive Deterioration - Quality of Life (TUDD-QoL)
Participants with PD-L1 CPS ≥ 1, except those randomized exclusively in the Chinese population
|
5.59 Months
Interval 3.25 to 6.6
|
4.07 Months
Interval 2.79 to 5.36
|
SECONDARY outcome
Timeframe: From randomization until the first date of a definititve clincial decline from baseline in PF scale score (Up to approximately 38 months)Population: All randomized participants overall and participants with PD-L1 CPS ≥ 1 (except those randomized exclusively in the Chinese population)
TUDD-PF is defined as time from randomization until the first date of a definitive clinically meaningful decline from baseline in EORTC QLQ-C30 physical function scale score. A definitive deterioration is defined as when all subsequent PRO assessments after a deterioration also reach or exceed the pre-defined meaningful change threshold. A 10-point decrease from baseline will be considered the meaning change threshold (MCT) for the physical function scale.
Outcome measures
| Measure |
Arm B
n=360 Participants
Regorafenib 160 mg daily for 21 days of a 28-day cycle or TAS-102 35 mg/m\^2 twice daily for Days 1 to 5 and Days 8 to 12 of each 28-day cycle
|
Arm A
n=359 Participants
Relatlimab 480 mg + Nivolumab 480 mg every 4 weeks
|
|---|---|---|
|
Time Until Definitive Deterioration - Physical Function (TUDD-PF)
Overall, except those randomized exclusively in the Chinese population
|
6.57 Months
Interval 5.72 to 8.57
|
5.29 Months
Interval 3.78 to 5.78
|
|
Time Until Definitive Deterioration - Physical Function (TUDD-PF)
Participants with PD-L1 CPS ≥ 1, except those randomized exclusively in the Chinese population
|
6.60 Months
Interval 5.26 to 8.57
|
3.78 Months
Interval 3.02 to 5.32
|
SECONDARY outcome
Timeframe: From date of randomization to the date of first documented progression or death, whichever occurs first (Up to approximately 38 months)Population: All randomized participants overall and participants with PD-L1 CPS ≥ 1 (except those randomized exclusively in the Chinese population)
PFS is defined as the time from randomization to first documented progression (PD) or death due to any cause, whichever is earlier. PD=At least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
Arm B
n=360 Participants
Regorafenib 160 mg daily for 21 days of a 28-day cycle or TAS-102 35 mg/m\^2 twice daily for Days 1 to 5 and Days 8 to 12 of each 28-day cycle
|
Arm A
n=359 Participants
Relatlimab 480 mg + Nivolumab 480 mg every 4 weeks
|
|---|---|---|
|
Progression Free Survival (PFS) Per Investigator
Participants with PD-L1 CPS ≥ 1, except those randomized exclusively in the Chinese population
|
2.10 Months
Interval 1.94 to 3.55
|
1.87 Months
Interval 1.84 to 1.91
|
|
Progression Free Survival (PFS) Per Investigator
Overall, except those randomized exclusively in the Chinese population
|
2.10 Months
Interval 1.97 to 3.22
|
1.87 Months
Interval 1.84 to 1.87
|
SECONDARY outcome
Timeframe: From randomization until the date of objectively documented response (Up to approximately 38 months)Population: All randomized participants overall and participants with PD-L1 CPS ≥ 1 (except those randomized exclusively in the Chinese population)
ORR is defined as the percent of participants with a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR). CR=Disappearance of all target lesions. PR=At least a 30% decrease in the sum of diameters of target lesions.
Outcome measures
| Measure |
Arm B
n=360 Participants
Regorafenib 160 mg daily for 21 days of a 28-day cycle or TAS-102 35 mg/m\^2 twice daily for Days 1 to 5 and Days 8 to 12 of each 28-day cycle
|
Arm A
n=359 Participants
Relatlimab 480 mg + Nivolumab 480 mg every 4 weeks
|
|---|---|---|
|
Objective Response Rate (ORR) Per Investigator
Overall, except those randomized exclusively in the Chinese population
|
1.4 Percent of participants
Interval 0.5 to 3.2
|
3.3 Percent of participants
Interval 1.7 to 5.8
|
|
Objective Response Rate (ORR) Per Investigator
Participants with PD-L1 CPS ≥ 1, except those randomized exclusively in the Chinese population
|
2.8 Percent of participants
Interval 0.9 to 6.4
|
3.3 Percent of participants
Interval 1.2 to 7.0
|
SECONDARY outcome
Timeframe: From date of randomization to the date of first documented progression or death, whichever occurs first (Up to approximately 38 months)Population: All responders overall and with PD-L1 CPS ≥ 1 (except those randomized exclusively in the Chinese population)
DoR is defined as the time between the date of first confirmed documented response (CR or PR) to the date of the first documented tumor progression as determined by BICR (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. CR=Disappearance of all target lesions. PR=At least a 30% decrease in the sum of diameters of target lesions. PD=At least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
Arm B
n=5 Participants
Regorafenib 160 mg daily for 21 days of a 28-day cycle or TAS-102 35 mg/m\^2 twice daily for Days 1 to 5 and Days 8 to 12 of each 28-day cycle
|
Arm A
n=12 Participants
Relatlimab 480 mg + Nivolumab 480 mg every 4 weeks
|
|---|---|---|
|
Duration of Response (DoR) Per Investigator
Overall, except those randomized exclusively in the Chinese population
|
5.52 Months
Interval 4.4 to 10.0
|
8.34 Months
Interval 0.0 to 17.0
|
|
Duration of Response (DoR) Per Investigator
Participants with PD-L1 CPS ≥ 1, except those randomized exclusively in the Chinese population
|
5.52 Months
Interval 4.4 to 10.0
|
8.34 Months
Interval 3.7 to 17.0
|
Adverse Events
Arm A
Serious events: 227 serious events
Other events: 333 other events
Deaths: 292 deaths
Arm B
Serious events: 195 serious events
Other events: 323 other events
Deaths: 304 deaths
Serious adverse events
| Measure |
Arm A
n=383 participants at risk
Relatlimab 480 mg + Nivolumab 480 mg every 4 weeks
|
Arm B
n=358 participants at risk
Regorafenib 160 mg daily for 21 days of a 28-day cycle or TAS-102 35 mg/m\^2 twice daily for Days 1 to 5 and Days 8 to 12 of each 28-day cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
4/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial tachycardia
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Myocardial infarction
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Myocarditis
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Pericarditis malignant
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Ventricular tachycardia
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Adrenal insufficiency
|
1.0%
4/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Endocrine disorder
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypophysitis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypopituitarism
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Thyroiditis
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal distension
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
7/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.0%
7/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Ascites
|
0.78%
3/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Colitis
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
5/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dysphagia
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Enteritis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.78%
3/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Ileal perforation
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Ileus
|
0.78%
3/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
4/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.6%
10/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.0%
7/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.78%
3/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Malignant ascites
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Malignant gastrointestinal obstruction
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Oesophagitis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.0%
4/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.84%
3/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Stomatitis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Subileus
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
7/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Asthenia
|
0.78%
3/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Cardiac death
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Chest pain
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Death
|
1.0%
4/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
8/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Disease progression
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Fatigue
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
General physical health deterioration
|
1.6%
6/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
4/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Generalised oedema
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Hyperpyrexia
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Hyperthermia
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Inflammation
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Malaise
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Multiple organ dysfunction syndrome
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Oedema peripheral
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Pain
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Polyserositis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Pyrexia
|
1.3%
5/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.84%
3/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Serositis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholangitis
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholecystitis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholestasis
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.78%
3/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatic failure
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatitis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.84%
3/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Jaundice
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
4/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Malignant biliary obstruction
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Abdominal infection
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Abscess
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Anal abscess
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bacteraemia
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Biliary tract infection
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Cellulitis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Device related infection
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Febrile infection
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Gastroenteritis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Infection
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Influenza
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Klebsiella sepsis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Klebsiella urinary tract infection
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Liver abscess
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Lower respiratory tract infection
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Mycoplasma infection
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Nosocomial infection
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Peritonitis
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pleural infection
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
0.78%
3/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.0%
7/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pyelonephritis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sepsis
|
1.3%
5/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.84%
3/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Septic shock
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Spinal cord abscess
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
1.0%
4/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urosepsis
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Viral sepsis
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Fall
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Overdose
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood bilirubin increased
|
0.78%
3/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatine phosphokinase increased
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatinine increased
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
General physical condition abnormal
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Platelet count decreased
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Cachexia
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.78%
3/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Mineral deficiency
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.78%
3/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated myositis
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
4/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
27.9%
107/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
32.7%
117/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.3%
5/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
1.8%
7/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
6/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour fistulisation
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Brain oedema
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cerebral infarction
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Hydrocephalus
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Malignant spinal cord compression
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Spinal cord compression
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Transient ischaemic attack
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.84%
3/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Haematuria
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Malignant urinary tract obstruction
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Renal failure
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Urinary incontinence
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Urinary retention
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
2/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.0%
4/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
4/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pleural effusion
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
5/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.84%
3/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.84%
3/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Deep vein thrombosis
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Embolism venous
|
0.00%
0/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Endothelial dysfunction
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Haematoma
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Infarction
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Superior vena cava occlusion
|
0.26%
1/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
Arm A
n=383 participants at risk
Relatlimab 480 mg + Nivolumab 480 mg every 4 weeks
|
Arm B
n=358 participants at risk
Regorafenib 160 mg daily for 21 days of a 28-day cycle or TAS-102 35 mg/m\^2 twice daily for Days 1 to 5 and Days 8 to 12 of each 28-day cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
17.5%
67/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.1%
90/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.0%
4/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.3%
62/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hyperthyroidism
|
6.5%
25/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.28%
1/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypothyroidism
|
10.4%
40/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.1%
11/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
12.8%
49/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.9%
39/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
12.0%
46/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.1%
36/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
12.8%
49/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
23.7%
85/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
22.2%
85/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
29.1%
104/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
12.3%
47/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.0%
50/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Asthenia
|
17.5%
67/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.6%
63/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Fatigue
|
18.0%
69/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.9%
64/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Malaise
|
2.6%
10/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
19/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Oedema peripheral
|
7.8%
30/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.6%
13/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Pyrexia
|
14.4%
55/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.2%
40/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
5.2%
20/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.5%
16/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
11.7%
45/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.7%
31/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
14.9%
57/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.1%
36/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood alkaline phosphatase increased
|
6.8%
26/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
18/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood bilirubin increased
|
8.4%
32/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.4%
30/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatine phosphokinase increased
|
7.0%
27/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
6/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Neutrophil count decreased
|
1.8%
7/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.8%
78/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Platelet count decreased
|
3.9%
15/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
34/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Weight decreased
|
4.7%
18/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
18/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
White blood cell count decreased
|
1.3%
5/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.0%
43/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.1%
73/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.4%
73/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.7%
22/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
18/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.7%
18/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.1%
22/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.6%
29/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
18/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
22/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
15/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.0%
23/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.4%
5/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
5.5%
21/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
15/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Proteinuria
|
3.7%
14/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.6%
20/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.4%
32/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
15/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.52%
2/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
19/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.6%
29/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
19/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
1.6%
6/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.6%
56/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.3%
24/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.0%
7/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.5%
21/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.6%
13/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertension
|
2.1%
8/383 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.6%
38/358 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 135 days post last dose (up to approximately 27 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
- Publication restrictions are in place
Restriction type: OTHER