Trial Outcomes & Findings for An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC (NCT NCT02409368)
NCT ID: NCT02409368
Last Updated: 2022-11-14
Results Overview
The total number of participants with high grade treatment related select adverse events.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
812 participants
Primary outcome timeframe
From first dose to time of analysis of primary endpoint (approximately up to 34 months)
Results posted on
2022-11-14
Participant Flow
1 participant was ECOG PS 3 and thus outside the scope of the protocol and excluded from analysis. There were 2 ECOG classification periods during the course of this study. The population from the first was used in the Primary Outcome Measure analysis. The population from the second was used in the Baseline Characteristics, Secondary Outcome Measures, and Adverse Event analysis. 1 participant was lost from the Primary Completion ECOG Classification that was accounted for at Study Completion.
Participant milestones
| Measure |
ECOG (PS0)
ECOG Performance Status 0
Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG (PS1)
ECOG Performance Status 1
nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG Performance Status 2
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
ECOG (PS3)
ECOG Performance Status 3
nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
|---|---|---|---|---|
|
Original Classification
STARTED
|
173
|
534
|
103
|
1
|
|
Original Classification
COMPLETED
|
173
|
534
|
103
|
1
|
|
Original Classification
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
ECOG Reclassification
STARTED
|
172
|
537
|
102
|
1
|
|
ECOG Reclassification
COMPLETED
|
0
|
0
|
0
|
0
|
|
ECOG Reclassification
NOT COMPLETED
|
172
|
537
|
102
|
1
|
Reasons for withdrawal
| Measure |
ECOG (PS0)
ECOG Performance Status 0
Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG (PS1)
ECOG Performance Status 1
nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG Performance Status 2
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
ECOG (PS3)
ECOG Performance Status 3
nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
|---|---|---|---|---|
|
ECOG Reclassification
Adverse event unrelated to study drug
|
17
|
49
|
12
|
0
|
|
ECOG Reclassification
Death
|
1
|
5
|
0
|
0
|
|
ECOG Reclassification
Disease Progression
|
113
|
382
|
70
|
1
|
|
ECOG Reclassification
Lost to Follow-up
|
1
|
5
|
0
|
0
|
|
ECOG Reclassification
Maximum clinical benefit
|
6
|
5
|
0
|
0
|
|
ECOG Reclassification
Poor/non-compliance
|
0
|
3
|
2
|
0
|
|
ECOG Reclassification
Study drug toxicity
|
17
|
42
|
7
|
0
|
|
ECOG Reclassification
Participant no longer meets study criteria
|
3
|
8
|
3
|
0
|
|
ECOG Reclassification
Participant request to discontinue study treatment
|
6
|
6
|
2
|
0
|
|
ECOG Reclassification
Participant withdrew consent
|
2
|
3
|
4
|
0
|
|
ECOG Reclassification
Other Reasons
|
5
|
26
|
2
|
0
|
|
ECOG Reclassification
Administrative reason by sponsor
|
1
|
3
|
0
|
0
|
Baseline Characteristics
An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC
Baseline characteristics by cohort
| Measure |
ECOG (PS0)
n=172 Participants
ECOG Performance Status 0
Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG (PS1)
n=537 Participants
ECOG Performance Status 1
nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG Performance Status 2
n=102 Participants
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
ECOG (PS3)
n=1 Participants
ECOG Performance Status 3
nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
Total
n=812 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.6 Years
STANDARD_DEVIATION 8.28 • n=93 Participants
|
66.1 Years
STANDARD_DEVIATION 8.27 • n=4 Participants
|
67.9 Years
STANDARD_DEVIATION 7.29 • n=27 Participants
|
71 Years
STANDARD_DEVIATION NA • n=483 Participants
|
65.8 Years
STANDARD_DEVIATION 8.24 • n=36 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=93 Participants
|
111 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
171 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=93 Participants
|
426 Participants
n=4 Participants
|
80 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
641 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
61 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
159 Participants
n=93 Participants
|
500 Participants
n=4 Participants
|
91 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
751 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
165 Participants
n=93 Participants
|
530 Participants
n=4 Participants
|
102 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
798 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: From first dose to time of analysis of primary endpoint (approximately up to 34 months)Population: All Treated participants
The total number of participants with high grade treatment related select adverse events.
Outcome measures
| Measure |
ECOG (PS0)
n=173 Participants
ECOG Performance Status 0
Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG (PS1)
n=534 Participants
ECOG Performance Status 1
Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG Performance Status 2
n=103 Participants
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
|---|---|---|---|
|
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events
Hepatic
|
3 Participants
|
11 Participants
|
2 Participants
|
|
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events
Skin
|
1 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events
Gastrointestinal
|
1 Participants
|
10 Participants
|
0 Participants
|
|
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events
Endocrine
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events
Pulmonary
|
2 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events
Renal
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events
Hypersensitivity/ Infusion reaction
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose up to 100 days post last dose (up to 76 months)Population: All treated participants with ECOG PS Grade 0-2
The total number of participants with high grade select adverse events. High grade is defined as Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grades 3-4. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
Outcome measures
| Measure |
ECOG (PS0)
n=172 Participants
ECOG Performance Status 0
Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG (PS1)
n=537 Participants
ECOG Performance Status 1
Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG Performance Status 2
n=102 Participants
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
|---|---|---|---|
|
Number of Participants With High Grade Select Adverse Events
Skin
|
2 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants With High Grade Select Adverse Events
Gastrointestinal
|
1 Participants
|
11 Participants
|
0 Participants
|
|
Number of Participants With High Grade Select Adverse Events
Endocrine
|
5 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With High Grade Select Adverse Events
Hepatic
|
6 Participants
|
19 Participants
|
3 Participants
|
|
Number of Participants With High Grade Select Adverse Events
Pulmonary
|
3 Participants
|
9 Participants
|
1 Participants
|
|
Number of Participants With High Grade Select Adverse Events
Renal
|
0 Participants
|
7 Participants
|
1 Participants
|
|
Number of Participants With High Grade Select Adverse Events
Hypersensitivity/ Infusion reaction
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose up to 100 days post last dose (up to approximately 65 months)Population: All treated participants with ECOG PS Grade 0-2
Median Time to onset of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
Outcome measures
| Measure |
ECOG (PS0)
n=172 Participants
ECOG Performance Status 0
Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG (PS1)
n=537 Participants
ECOG Performance Status 1
Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG Performance Status 2
n=102 Participants
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
|---|---|---|---|
|
Median Time to Onset of Any Grade Select Adverse Events
Endrocrine
|
12.79 Weeks
Interval 4.0 to 121.6
|
10.14 Weeks
Interval 1.9 to 165.1
|
19.86 Weeks
Interval 6.1 to 55.4
|
|
Median Time to Onset of Any Grade Select Adverse Events
Gastrointestinal
|
11.71 Weeks
Interval 0.1 to 88.0
|
8.86 Weeks
Interval 0.1 to 228.1
|
6.00 Weeks
Interval 0.3 to 64.3
|
|
Median Time to Onset of Any Grade Select Adverse Events
Hepatic
|
26.64 Weeks
Interval 1.4 to 234.1
|
11.43 Weeks
Interval 2.0 to 90.1
|
8.14 Weeks
Interval 2.0 to 88.1
|
|
Median Time to Onset of Any Grade Select Adverse Events
Pulmonary
|
33.43 Weeks
Interval 7.4 to 169.4
|
11.50 Weeks
Interval 0.6 to 166.0
|
3.93 Weeks
Interval 0.1 to 26.3
|
|
Median Time to Onset of Any Grade Select Adverse Events
Renal
|
28.86 Weeks
Interval 4.1 to 129.9
|
22.71 Weeks
Interval 0.1 to 246.0
|
10.29 Weeks
Interval 1.4 to 52.9
|
|
Median Time to Onset of Any Grade Select Adverse Events
Skin
|
12.14 Weeks
Interval 0.1 to 92.1
|
7.86 Weeks
Interval 0.1 to 200.1
|
14.71 Weeks
Interval 2.1 to 81.7
|
|
Median Time to Onset of Any Grade Select Adverse Events
Hypersensitivity/Infusion Reaction
|
1.93 Weeks
Interval 1.7 to 2.1
|
2.21 Weeks
Interval 0.3 to 20.3
|
2.14 Weeks
Interval 2.1 to 28.6
|
SECONDARY outcome
Timeframe: From first dose to up to 100 days post last dose (up to approximately 45 months)Population: All treated participants with ECOG PS Grade 0-2
Median time to resolution of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
Outcome measures
| Measure |
ECOG (PS0)
n=172 Participants
ECOG Performance Status 0
Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG (PS1)
n=537 Participants
ECOG Performance Status 1
Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG Performance Status 2
n=102 Participants
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
|---|---|---|---|
|
Median Time to Resolution of Any Grade Select Adverse Events
Endrocrine
|
NA Weeks
Interval 109.0 to
Median and upper limit not reached due to insufficient number of events
|
169.43 Weeks
Interval 17.86 to
Upper limit not reached due to insufficient number of events
|
NA Weeks
Interval 6.14 to
Median and upper limit not reached due to insufficient number of events
|
|
Median Time to Resolution of Any Grade Select Adverse Events
Gastrointestinal
|
2.86 Weeks
Interval 0.43 to 5.14
|
2.00 Weeks
Interval 1.0 to 3.0
|
2.00 Weeks
Interval 0.43 to 5.71
|
|
Median Time to Resolution of Any Grade Select Adverse Events
Hepatic
|
4.57 Weeks
Interval 2.57 to 6.14
|
7.71 Weeks
Interval 4.86 to 17.14
|
3.57 Weeks
Interval 2.14 to 8.14
|
|
Median Time to Resolution of Any Grade Select Adverse Events
Pulmonary
|
3.00 Weeks
Interval 1.43 to
Upper limit not reached due to insufficient number of events
|
4.29 Weeks
Interval 2.14 to 6.0
|
2.29 Weeks
Interval 1.0 to
Upper limit not reached due to insufficient number of events
|
|
Median Time to Resolution of Any Grade Select Adverse Events
Renal
|
10.14 Weeks
Interval 2.14 to
Upper limit not reached due to insufficient number of events
|
6.14 Weeks
Interval 2.29 to 25.14
|
59.14 Weeks
Interval 0.57 to 59.14
|
|
Median Time to Resolution of Any Grade Select Adverse Events
Skin
|
NA Weeks
Interval 13.57 to
Median and upper limit not reached due to insufficient number of events
|
15.43 Weeks
Interval 8.71 to 52.86
|
5.71 Weeks
Interval 2.0 to
Upper limit not reached due to insufficient number of events
|
|
Median Time to Resolution of Any Grade Select Adverse Events
Hypersensitivity/Infusion Reaction
|
1.14 Weeks
Interval 0.14 to 2.14
|
0.14 Weeks
Interval 0.14 to 4.43
|
0.14 Weeks
Interval 0.14 to 0.71
|
SECONDARY outcome
Timeframe: From the first dosing up to the date of death (up to approximately 76 months)Population: All treated participants with ECOG PS Grade 0-2
Overall Survival (OS) is defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive. OS will be followed continuously while subjects are on treatment and every 3 months via in-person or phone contact after subjects discontinue the study drug.
Outcome measures
| Measure |
ECOG (PS0)
n=172 Participants
ECOG Performance Status 0
Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG (PS1)
n=537 Participants
ECOG Performance Status 1
Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG Performance Status 2
n=102 Participants
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
|---|---|---|---|
|
Overall Survival
|
12.1 Months
Interval 9.9 to 13.4
|
10.3 Months
Interval 9.3 to 11.3
|
5.2 Months
Interval 3.0 to 7.6
|
SECONDARY outcome
Timeframe: From first dose up to last dose (up to approximately 76 months)Population: All response evaluable participants
ORR is defined as the percentage of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). CR is defined as the disappearance of all target lesions; PR is defined by at least a 30% decrease in the sum of the longest diameter of target lesions. ORR as assessed by the investigator will be reported.
Outcome measures
| Measure |
ECOG (PS0)
n=150 Participants
ECOG Performance Status 0
Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG (PS1)
n=456 Participants
ECOG Performance Status 1
Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG Performance Status 2
n=64 Participants
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
|---|---|---|---|
|
Objective Response Rate (ORR)
|
8.0 Percentage
Interval 4.2 to 13.6
|
11.0 Percentage
Interval 8.2 to 14.2
|
1.6 Percentage
Interval 0.0 to 8.4
|
POST_HOC outcome
Timeframe: From first dose to up to 100 days post last dose (up to approximately 76 months)Population: All treated participants with ECOG PS Grade 0-2
The total number of participants with high grade treatment related select adverse events. High grade is defined as Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grades 3-4 or 5. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity. 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 |
ECOG (PS0)
n=172 Participants
ECOG Performance Status 0
Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG (PS1)
n=537 Participants
ECOG Performance Status 1
Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
|
ECOG Performance Status 2
n=102 Participants
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
|---|---|---|---|
|
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection
Skin
|
2 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection
Gastrointestinal
|
1 Participants
|
10 Participants
|
0 Participants
|
|
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection
Hepatic
|
4 Participants
|
12 Participants
|
2 Participants
|
|
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection
Pulmonary
|
2 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection
Renal
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection
Hypersensitivity/ Infusion reaction
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection
Endocrine
|
4 Participants
|
3 Participants
|
0 Participants
|
Adverse Events
ECOG Performance Status 0
Serious events: 115 serious events
Other events: 149 other events
Deaths: 131 deaths
ECOG Performance Status 1
Serious events: 375 serious events
Other events: 472 other events
Deaths: 446 deaths
ECOG Performance Status 2
Serious events: 84 serious events
Other events: 86 other events
Deaths: 90 deaths
ECOG Performance Status 3
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ECOG Performance Status 0
n=172 participants at risk
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
ECOG Performance Status 1
n=537 participants at risk
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
ECOG Performance Status 2
n=102 participants at risk
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
ECOG Performance Status 3
n=1 participants at risk
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
2/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
1.1%
6/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
2/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.0%
2/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Cardiac disorders
Cardiac failure
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.56%
3/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.56%
3/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Cardiac disorders
Cardiomegaly
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
2/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.56%
3/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Cardiac disorders
Pericardial effusion
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.56%
3/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.56%
3/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Endocrine disorders
Adrenal insufficiency
|
1.2%
2/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Endocrine disorders
Hyperthyroidism
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Endocrine disorders
Hypophysitis
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Endocrine disorders
Hypothyroidism
|
1.2%
2/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Ascites
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.56%
3/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
1.3%
7/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.74%
4/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.56%
3/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Stomatitis
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Asthenia
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Chest pain
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Death
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Fatigue
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
General physical health deterioration
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.74%
4/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Hernia obstructive
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Non-cardiac chest pain
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.74%
4/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Oedema peripheral
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Pain
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Pyrexia
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
1.5%
8/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Sudden cardiac death
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Sudden death
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.74%
4/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Systemic inflammatory response syndrome
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.0%
2/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Hepatobiliary disorders
Biliary tract disorder
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Abscess
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Anal abscess
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Bacteraemia
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Bacterial diarrhoea
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Bronchitis
|
2.3%
4/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
1.7%
9/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
COVID-19
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Clostridium colitis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Cystitis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.0%
2/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Infection
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.56%
3/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Lower respiratory tract infection
|
2.9%
5/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
3.9%
21/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
4.9%
5/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Pneumonia
|
11.6%
20/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
7.6%
41/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
9.8%
10/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Pulmonary sepsis
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.56%
3/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Respiratory tract infection
|
6.4%
11/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
4.7%
25/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.9%
3/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Sepsis
|
1.7%
3/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
1.3%
7/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Septic shock
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.56%
3/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Urinary tract infection
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.93%
5/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Injury, poisoning and procedural complications
Fall
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.0%
2/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.0%
2/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Investigations
Alanine aminotransferase increased
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Investigations
Aspartate aminotransferase increased
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Investigations
Liver function test increased
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Metabolism and nutrition disorders
Cachexia
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
2/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.2%
12/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.9%
3/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.2%
2/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.56%
3/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.0%
2/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.7%
3/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular thyroid cancer
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
34.3%
59/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
38.4%
206/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
56.9%
58/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.56%
3/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine adenocarcinoma
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour compression
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.93%
5/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.0%
2/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Coma
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Dizziness
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Epilepsy
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Intracranial pressure increased
|
1.2%
2/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Seizure
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.56%
3/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Syncope
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.9%
3/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Tremor
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Psychiatric disorders
Agitation
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Psychiatric disorders
Confusional state
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Psychiatric disorders
Delirium
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Psychiatric disorders
Mania
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.74%
4/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.74%
4/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.0%
2/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.2%
2/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
1.3%
7/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
4.9%
5/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.2%
9/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
5.2%
28/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
9.8%
10/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.1%
7/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.0%
11/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.9%
3/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oesophagobronchial fistula
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
3/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
1.9%
10/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.0%
2/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
4/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.8%
15/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
3/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
1.1%
6/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.7%
3/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
1.9%
10/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Vascular disorders
Embolism
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Vascular disorders
Hypertension
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Vascular disorders
Hypotension
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Vascular disorders
Superior vena cava occlusion
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.74%
4/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Vascular disorders
Venous thrombosis limb
|
0.58%
1/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
Other adverse events
| Measure |
ECOG Performance Status 0
n=172 participants at risk
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
ECOG Performance Status 1
n=537 participants at risk
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
ECOG Performance Status 2
n=102 participants at risk
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
ECOG Performance Status 3
n=1 participants at risk
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.4%
23/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
18.1%
97/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
20.6%
21/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Endocrine disorders
Hypothyroidism
|
14.5%
25/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
6.9%
37/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
5.9%
6/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Constipation
|
10.5%
18/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
14.9%
80/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
15.7%
16/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
15.1%
26/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
18.6%
100/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
15.7%
16/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Nausea
|
11.6%
20/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
13.2%
71/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
15.7%
16/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
9/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
6.3%
34/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
8.8%
9/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Asthenia
|
17.4%
30/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
24.4%
131/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
14.7%
15/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Fatigue
|
23.3%
40/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
22.5%
121/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
24.5%
25/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Non-cardiac chest pain
|
3.5%
6/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
6.3%
34/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
4.9%
5/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Oedema peripheral
|
4.1%
7/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
5.6%
30/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
13.7%
14/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Pyrexia
|
5.2%
9/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
9.1%
49/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
7.8%
8/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Lower respiratory tract infection
|
10.5%
18/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
9.5%
51/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
6.9%
7/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Respiratory tract infection
|
5.8%
10/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
6.9%
37/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
5.9%
6/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
10/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
5.4%
29/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.0%
2/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Investigations
Alanine aminotransferase increased
|
7.0%
12/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
5.6%
30/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
4.9%
5/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Investigations
Aspartate aminotransferase increased
|
8.7%
15/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
5.2%
28/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
4.9%
5/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Investigations
Blood creatinine increased
|
5.2%
9/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
6.3%
34/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
4.9%
5/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Investigations
Weight decreased
|
4.7%
8/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
7.8%
42/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
6.9%
7/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.0%
24/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
27.4%
147/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
23.5%
24/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.5%
6/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
7.3%
39/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
5.9%
6/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.4%
11/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
5.0%
27/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
4.9%
5/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.0%
24/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
9.7%
52/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
6.9%
7/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.4%
11/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
8.6%
46/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
6.9%
7/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Headache
|
5.8%
10/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
6.7%
36/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.9%
3/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.6%
44/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
25.0%
134/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
18.6%
19/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.6%
44/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
31.1%
167/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
27.5%
28/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.4%
11/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
8.8%
47/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
9.8%
10/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.2%
9/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
10.8%
58/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
9.8%
10/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.8%
10/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
7.3%
39/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
4.9%
5/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Endocrine disorders
Hyperthyroidism
|
7.6%
13/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
3.4%
18/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
2/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
5.2%
28/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.9%
3/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Gastrointestinal disorders
Stomatitis
|
2.9%
5/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.6%
14/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
6.9%
7/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Chest pain
|
5.8%
10/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
4.5%
24/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Influenza like illness
|
1.7%
3/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.74%
4/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.0%
2/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
General disorders
Peripheral swelling
|
1.2%
2/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
1.5%
8/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.0%
2/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
11/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.8%
15/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Oral candidiasis
|
2.3%
4/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
4.8%
26/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.9%
3/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Pneumonia
|
6.4%
11/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
4.5%
24/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
4.9%
5/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Infections and infestations
Tooth infection
|
1.2%
2/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.19%
1/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.1%
7/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
3.7%
20/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
5.9%
6/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.1%
7/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
4.5%
24/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
6.9%
7/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
4/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
4.7%
25/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
5.9%
6/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Dizziness
|
1.7%
3/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
5.2%
28/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
7.8%
8/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Nervous system disorders
Seizure
|
0.00%
0/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.37%
2/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Psychiatric disorders
Anxiety
|
5.2%
9/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.2%
12/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
2/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
1.1%
6/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.98%
1/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.8%
10/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
4.1%
22/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
2.0%
2/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.7%
3/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
4.8%
26/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
5.9%
6/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.1%
7/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
4.8%
26/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
5.9%
6/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
|
Vascular disorders
Hypertension
|
7.0%
12/172 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
3.5%
19/537 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/102 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)
|
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