Trial Outcomes & Findings for An Investigational Immunotherapy Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Colorectal Cancer That Has Spread (NCT NCT03414983)
NCT ID: NCT03414983
Last Updated: 2023-11-18
Results Overview
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by BICR (per RECIST 1.1), or death due to any cause, whichever occurs first. Baseline tumor assessment is defined as tumor scans prior to or on randomization date. Participants who did not have documented progression per BICR and who did not die or participants who started any subsequent anti-cancer therapy without a prior reported progression per BICR will be censored at the date of the last tumor assessment on or prior to initiation of the subsequent anticancer therapy, if any. Participants who die without a reported prior progression per BICR will be considered to have progressed on the date of death. Participants who did not have any baseline or post baseline tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
196 participants
Primary outcome timeframe
From randomization to up to the date of the first documented progression (up to 16 months)
Results posted on
2023-11-18
Participant Flow
Participant milestones
| Measure |
Arm A: NIV+mFOLFOX+BEV
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Pre-Treatment
STARTED
|
127
|
68
|
|
Pre-Treatment
COMPLETED
|
123
|
62
|
|
Pre-Treatment
NOT COMPLETED
|
4
|
6
|
|
Treatment
STARTED
|
123
|
62
|
|
Treatment
COMPLETED
|
9
|
0
|
|
Treatment
NOT COMPLETED
|
114
|
62
|
Reasons for withdrawal
| Measure |
Arm A: NIV+mFOLFOX+BEV
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Pre-Treatment
Other reasons
|
1
|
0
|
|
Pre-Treatment
Participant no longer meets study criteria
|
2
|
3
|
|
Pre-Treatment
Participant withdrew consent
|
1
|
3
|
|
Treatment
Participant withdrew consent
|
4
|
3
|
|
Treatment
Participant request to discontinue study treatment
|
8
|
10
|
|
Treatment
Adverse Event Unrelated to Study Drug
|
5
|
2
|
|
Treatment
Death
|
0
|
1
|
|
Treatment
Study Drug Toxicity
|
10
|
5
|
|
Treatment
Disease Progression
|
75
|
29
|
|
Treatment
Not reported
|
1
|
0
|
|
Treatment
Other reasons
|
3
|
2
|
|
Treatment
Poor/non-compliance
|
2
|
0
|
|
Treatment
Maximum clinical benefit
|
5
|
9
|
|
Treatment
Lost to Follow-up
|
0
|
1
|
|
Treatment
Administrative reasons by sponsor
|
1
|
0
|
Baseline Characteristics
An Investigational Immunotherapy Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Colorectal Cancer That Has Spread
Baseline characteristics by cohort
| Measure |
Arm A: NIV+mFOLFOX+BEV
n=127 Participants
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=68 Participants
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.8 Years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
57.2 Years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
56.9 Years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
108 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
96 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to up to the date of the first documented progression (up to 16 months)Population: All Randomized Participants
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by BICR (per RECIST 1.1), or death due to any cause, whichever occurs first. Baseline tumor assessment is defined as tumor scans prior to or on randomization date. Participants who did not have documented progression per BICR and who did not die or participants who started any subsequent anti-cancer therapy without a prior reported progression per BICR will be censored at the date of the last tumor assessment on or prior to initiation of the subsequent anticancer therapy, if any. Participants who die without a reported prior progression per BICR will be considered to have progressed on the date of death. Participants who did not have any baseline or post baseline tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date.
Outcome measures
| Measure |
Arm A: NIV+mFOLFOX+BEV
n=127 Participants
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=68 Participants
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)
|
11.86 Months
Interval 8.94 to 15.7
|
11.93 Months
Interval 10.09 to 12.19
|
SECONDARY outcome
Timeframe: From randomization up to the date of the first documented progression (up to approximately 44 months)Population: All Randomized Participants
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by Investigator Assessment, or death due to any cause, whichever occurs first. Baseline tumor assessment is defined as tumor scans prior to or on randomization date. Participants who did not have documented progression per Investigator Assessment and who did not die or participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the date of the last tumor assessment on or prior to initiation of the subsequent anticancer therapy, if any. Participants who die without a reported prior progression per Investigator Assessment will be considered to have progressed on the date of death. Participants who did not have any baseline or post baseline tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date.
Outcome measures
| Measure |
Arm A: NIV+mFOLFOX+BEV
n=127 Participants
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=68 Participants
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Progression Free Survival (PFS) Per Investigator Assessment
|
13.77 Months
Interval 11.53 to 15.7
|
12.19 Months
Interval 10.25 to 14.06
|
SECONDARY outcome
Timeframe: From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months)Population: All Randomized Participants
ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response designation as determined by BICR per RECIST 1.1, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to \<10 mm.
Outcome measures
| Measure |
Arm A: NIV+mFOLFOX+BEV
n=127 Participants
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=68 Participants
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
|
60.6 Percentage of Participants
Interval 51.6 to 69.2
|
45.6 Percentage of Participants
Interval 33.5 to 58.1
|
SECONDARY outcome
Timeframe: From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months)Population: All Randomized Participants
ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response designation as determined by tumor assessments by the Investigator per RECIST 1.1, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to \<10 mm.
Outcome measures
| Measure |
Arm A: NIV+mFOLFOX+BEV
n=127 Participants
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=68 Participants
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Objective Response Rate (ORR) Per Investigator Assessment
|
60.6 Percentage of participants
Interval 51.6 to 69.2
|
52.9 Percentage of participants
Interval 40.4 to 65.2
|
SECONDARY outcome
Timeframe: From randomization up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 44 months)Population: All randomized participants with a CR or PR that were assessed by BICR
Duration of objective response (DoR) is defined as the time between the date of first confirmed complete response (CR) or partial response (PR) to the date of the first documented tumor progression as assessed by the BICR based on RECIST 1.1 criteria or death due to any cause, whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to \<10 mm.
Outcome measures
| Measure |
Arm A: NIV+mFOLFOX+BEV
n=77 Participants
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=31 Participants
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
|
12.88 Months
Interval 9.0 to 14.72
|
9.26 Months
Interval 7.49 to 11.3
|
SECONDARY outcome
Timeframe: From randomization up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 44 months)Population: All randomized participants with a CR or PR
Duration of objective response (DoR) is defined as the time between the date of first confirmed complete response (CR) or partial response (PR) to the date of the first documented tumor progression as assessed by the investigator based on RECIST 1.1 criteria or death due to any cause, whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to \<10 mm.
Outcome measures
| Measure |
Arm A: NIV+mFOLFOX+BEV
n=77 Participants
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=36 Participants
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Duration of Response (DoR) Per Investigator Assessment
|
12.48 Months
Interval 8.87 to 16.72
|
11.07 Months
Interval 9.43 to 17.31
|
SECONDARY outcome
Timeframe: From the randomization date up to the date of the first confirmed CR or PR (up to approximately 44 months)Population: All randomized participants with a CR or PR
Time to objective response (TTR) is defined as the time from the randomization date to the date of the first confirmed complete response (CR) or partial response (PR) as assessed by BICR. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to \<10 mm. TTR is derived for responders only.
Outcome measures
| Measure |
Arm A: NIV+mFOLFOX+BEV
n=77 Participants
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=31 Participants
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Time to Objective Response Per Blinded Independent Central Review (BICR)
|
2.83 Months
Standard Deviation 1.51
|
2.83 Months
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: From the randomization date up to the date of the first confirmed CR or PR (up to 44 months)Population: All randomized participants with a CR or PR
TTR is defined as the time from the randomization date to the date of the first confirmed complete response (CR) or partial response (PR) as assessed by investigator. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to \<10 mm. TTR is derived for responders only.
Outcome measures
| Measure |
Arm A: NIV+mFOLFOX+BEV
n=77 Participants
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=36 Participants
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Time to Objective Response Per Investigator Assessment
|
2.83 Months
Standard Deviation 2.51
|
2.83 Months
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: From the date of randomization up to the date of death (up to 44 months)Population: All Randomized Participants
Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.
Outcome measures
| Measure |
Arm A: NIV+mFOLFOX+BEV
n=127 Participants
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=68 Participants
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Overall Survival (OS)
|
30.52 Months
Interval 25.2 to 39.39
|
31.77 Months
Interval 24.38 to 38.7
|
SECONDARY outcome
Timeframe: From first dose to 30 days post last dose (up to 45 months)Population: All treated participants
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, 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; Grade 5 events are fatal.
Outcome measures
| Measure |
Arm A: NIV+mFOLFOX+BEV
n=123 Participants
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=62 Participants
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
122 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: From first dose to 30 days post last dose (up to 45 months)Population: All treated participants
Number of participants with any grade of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine safety and tolerability. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.
Outcome measures
| Measure |
Arm A: NIV+mFOLFOX+BEV
n=123 Participants
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=62 Participants
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
57 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: From first dose up to 6 weeks post last dose (up to 46 months)Population: All treated participants
The number of participants who died during the treatment period
Outcome measures
| Measure |
Arm A: NIV+mFOLFOX+BEV
n=123 Participants
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=62 Participants
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Number of Participants Experiencing Death
|
87 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: From first dose up to 30 days post last dose (up to 45 months)Population: All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
Outcome measures
| Measure |
Arm A: NIV+mFOLFOX+BEV
n=123 Participants
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=62 Participants
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT OR AST > 20XULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 1.5XULN WITHIN ONE DAY
|
2 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN ONE DAY
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT OR AST > 3XULN
|
16 Participants
|
6 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT OR AST > 5XULN
|
7 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT OR AST > 10XULN
|
2 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
TOTAL BILIRUBIN > 2XULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALP > 1.5XULN
|
39 Participants
|
20 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 1.5XULN WITHIN 30 DAYS
|
2 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN 30 DAYS
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose up to 30 days post last dose (up to 45 months)Population: All Treated Participants with at Least One On-Treatment TSH measurement
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
Outcome measures
| Measure |
Arm A: NIV+mFOLFOX+BEV
n=123 Participants
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=60 Participants
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN
|
25 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
|
8 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN
|
45 Participants
|
23 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN WITH TSH <= ULN AT BASELINE
|
37 Participants
|
16 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN
|
20 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
|
11 Participants
|
9 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN WITH FT3/FT4 TEST MISSING
|
14 Participants
|
12 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN WITH TSH >= LLN AT BASELINE
|
22 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN
|
13 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN WITH FT3/FT4 TEST MISSING
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months)Population: All randomized participants
Disease Control Rate (DCR) is defined as the percentage of participants whose Best Overall Response (BOR) is complete response (CR) or partial response (PR) or stable disease (SD). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Arm A: NIV+mFOLFOX+BEV
n=127 Participants
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=68 Participants
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Disease Control Rate (DCR) Per Blinded Independent Central Review (BICR)
|
91.3 Percentage of participants
Interval 85.0 to 95.6
|
83.8 Percentage of participants
Interval 72.9 to 91.6
|
SECONDARY outcome
Timeframe: From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months)Population: All randomized participants
Disease Control Rate (DCR) is defined as the percentage of participants whose Best Overall Response (BOR) is complete response (CR) or partial response (PR) or stable disease (SD). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Arm A: NIV+mFOLFOX+BEV
n=127 Participants
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=68 Participants
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Disease Control Rate (DCR) Per Investigator
|
85.8 Percentage of participants
Interval 85.0 to 95.6
|
77.9 Percentage of participants
Interval 66.2 to 87.1
|
POST_HOC outcome
Timeframe: From randomization to up to the date of the first documented progression (up to 44 months)Population: All Randomized Participants
PFS is the time from randomization to the date of first documented progression, as determined by BICR, or death due to any cause, whichever occurs first. Baseline tumor assessment is defined as tumor scans prior to or on randomization date. Participants who did not have documented progression and did not die or participants who started any subsequent anti-cancer therapy without a prior reported progression were censored on date of last tumor assessment on or prior to initiation of the subsequent anticancer therapy, if any. Participants who died without prior progression were considered to have progressed on the date of death. Participants who did not have any baseline assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) were censored at the randomization date. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date.
Outcome measures
| Measure |
Arm A: NIV+mFOLFOX+BEV
n=127 Participants
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=68 Participants
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR) - Extended Collection
|
11.99 Months
Interval 9.99 to 15.74
|
12.02 Months
Interval 10.25 to 13.37
|
Adverse Events
Arm A: NIV+mFOLFOX+BEV
Serious events: 67 serious events
Other events: 122 other events
Deaths: 89 deaths
Arm B: mFOLFOX+BEV
Serious events: 25 serious events
Other events: 61 other events
Deaths: 47 deaths
Serious adverse events
| Measure |
Arm A: NIV+mFOLFOX+BEV
n=123 participants at risk
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=62 participants at risk
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.6%
2/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Proctalgia
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 obstruction
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Autoimmune haemolytic anaemia
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.9%
6/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 arrest
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Intracardiac thrombus
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Tachycardia
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.1%
5/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
3/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.3%
9/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.4%
3/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Gastritis
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Immune-mediated enterocolitis
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.4%
3/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 perforation
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.2%
2/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.6%
2/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lower gastrointestinal haemorrhage
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Mesenteric vein thrombosis
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.4%
3/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 perforation
|
1.6%
2/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.4%
3/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.4%
3/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Asthenia
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Death
|
1.6%
2/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.2%
2/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Infusion site extravasation
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Non-cardiac chest pain
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pain
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pyrexia
|
2.4%
3/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 lesion
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 abscess
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 neck
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Clostridium difficile infection
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Diarrhoea infectious
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Diverticulitis
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Endocarditis bacterial
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Norovirus infection
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Oesophageal candidiasis
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Perirectal abscess
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.3%
4/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 pseudomonal
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Rectal abscess
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.9%
6/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Spontaneous bacterial peritonitis
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Vascular device infection
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 upper respiratory tract infection
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Forearm fracture
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Gastrointestinal anastomotic leak
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Incisional hernia
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 prolapse
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 potassium increased
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Diabetic ketoacidosis
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Failure to thrive
|
1.6%
2/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Metabolic acidosis
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.9%
6/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 liver
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 lung
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 ovary
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Depressed level of consciousness
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Syncope
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Depression
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Chronic obstructive pulmonary disease
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.6%
2/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pneumothorax
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.9%
6/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.2%
2/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 oedema
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypotension
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Orthostatic hypotension
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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: NIV+mFOLFOX+BEV
n=123 participants at risk
Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
|
Arm B: mFOLFOX+BEV
n=62 participants at risk
mFOLFOX6/bevacizumab (SOC) every 2 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
26.0%
32/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.4%
12/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
36.6%
45/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.6%
14/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
21.1%
26/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.3%
7/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Tachycardia
|
5.7%
7/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.7%
7/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
17.1%
21/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.7%
7/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.2%
2/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
32.5%
40/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
30.6%
19/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.8%
12/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
3/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.7%
7/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
42.3%
52/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.9%
21/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
60.2%
74/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
32.3%
20/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dry mouth
|
12.2%
15/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
3/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dyspepsia
|
12.2%
15/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.7%
6/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Gastrooesophageal reflux disease
|
5.7%
7/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.1%
5/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.9%
6/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
4/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
67.5%
83/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
56.5%
35/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Proctalgia
|
9.8%
12/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.2%
2/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
22.8%
28/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
29.0%
18/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Toothache
|
4.1%
5/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
4/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
39.8%
49/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.0%
13/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Asthenia
|
17.9%
22/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.7%
6/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Chills
|
13.8%
17/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Fatigue
|
59.3%
73/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
61.3%
38/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Influenza like illness
|
8.1%
10/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Malaise
|
5.7%
7/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
3/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Mucosal inflammation
|
12.2%
15/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.4%
12/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Non-cardiac chest pain
|
4.1%
5/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
4/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Oedema peripheral
|
9.8%
12/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.2%
2/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pain
|
6.5%
8/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
3/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pyrexia
|
28.5%
35/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.1%
10/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Temperature intolerance
|
26.0%
32/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.6%
14/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Immune system disorders
Hypersensitivity
|
8.1%
10/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.2%
2/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
13.8%
17/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.7%
6/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.4%
14/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.3%
7/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.9%
11/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Infusion related reaction
|
22.0%
27/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.1%
5/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
15.4%
19/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.7%
11/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
22.0%
27/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.1%
10/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
12.2%
15/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.1%
5/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.9%
11/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.2%
2/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
31.7%
39/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.4%
12/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.3%
25/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.1%
10/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
14.6%
18/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.4%
12/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
12.2%
15/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.1%
5/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
38.2%
47/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.8%
16/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
21.1%
26/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.1%
5/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.4%
14/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.2%
2/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
26.8%
33/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.1%
5/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.3%
9/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.6%
1/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.5%
8/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.7%
6/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
30.1%
37/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.5%
9/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
19.5%
24/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.5%
9/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.1%
5/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
4/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Muscle spasms
|
8.1%
10/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.9%
11/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
3/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.1%
10/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
3/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pain in extremity
|
17.1%
21/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
3/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
17.9%
22/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.5%
9/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dysgeusia
|
20.3%
25/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.4%
12/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.3%
25/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.7%
6/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypoaesthesia
|
3.3%
4/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.7%
6/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Neuropathy peripheral
|
43.9%
54/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.9%
21/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Neurotoxicity
|
9.8%
12/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.2%
2/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Paraesthesia
|
8.9%
11/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.1%
5/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Peripheral sensory neuropathy
|
36.6%
45/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
45.2%
28/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Taste disorder
|
6.5%
8/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.2%
2/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Anxiety
|
10.6%
13/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.2%
2/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Depression
|
10.6%
13/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
3/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Insomnia
|
26.8%
33/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.1%
10/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
14.6%
18/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.5%
9/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
23.6%
29/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.1%
10/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
13.0%
16/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.7%
6/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
21.1%
26/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
3/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Epistaxis
|
31.7%
39/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.0%
13/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hiccups
|
4.1%
5/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.7%
6/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Nasal congestion
|
6.5%
8/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
3/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Oropharyngeal pain
|
5.7%
7/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
4/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Rhinorrhoea
|
7.3%
9/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.1%
5/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Alopecia
|
8.1%
10/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.7%
6/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dry skin
|
13.8%
17/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.7%
6/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.4%
14/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.9%
8/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
10.6%
13/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.2%
2/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.4%
14/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
4/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.9%
11/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Skin hyperpigmentation
|
7.3%
9/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
4/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
32.5%
40/123 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.4%
12/62 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 45 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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