Trial Outcomes & Findings for An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026) (NCT NCT02041533)
NCT ID: NCT02041533
Last Updated: 2023-03-02
Results Overview
Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
541 participants
Primary outcome timeframe
From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)
Results posted on
2023-03-02
Participant Flow
Participant milestones
| Measure |
Nivolumab
Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
|
Investigator Choice of Chemotherapy
Administered in 3-week cycles for up to 6 cycles:
Squamous:
* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
* paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.
|
|---|---|---|
|
Pre-Treatment Period
STARTED
|
271
|
270
|
|
Pre-Treatment Period
COMPLETED
|
267
|
263
|
|
Pre-Treatment Period
NOT COMPLETED
|
4
|
7
|
|
Treatment Period
STARTED
|
267
|
263
|
|
Treatment Period
Received Optional Nivolumab
|
0
|
159
|
|
Treatment Period
COMPLETED
|
0
|
28
|
|
Treatment Period
NOT COMPLETED
|
267
|
235
|
Reasons for withdrawal
| Measure |
Nivolumab
Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
|
Investigator Choice of Chemotherapy
Administered in 3-week cycles for up to 6 cycles:
Squamous:
* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
* paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.
|
|---|---|---|
|
Pre-Treatment Period
Disease Progression
|
1
|
1
|
|
Pre-Treatment Period
Participant Withdrew Consent
|
0
|
5
|
|
Pre-Treatment Period
Participant no Longer Meets Study Criteria
|
3
|
1
|
|
Treatment Period
Disease progression
|
189
|
146
|
|
Treatment Period
Study drug toxicity
|
30
|
34
|
|
Treatment Period
Death
|
1
|
0
|
|
Treatment Period
Adverse event unrelated to study drug
|
22
|
23
|
|
Treatment Period
Participant request to discontinue study treatment
|
12
|
9
|
|
Treatment Period
Participant withdrew consent
|
2
|
2
|
|
Treatment Period
Maximum clinical benefit
|
0
|
18
|
|
Treatment Period
Poor/Non-compliance
|
1
|
0
|
|
Treatment Period
Administrative reason by sponsor
|
1
|
0
|
|
Treatment Period
Other reasons
|
9
|
2
|
|
Treatment Period
Not Reported
|
0
|
1
|
Baseline Characteristics
An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)
Baseline characteristics by cohort
| Measure |
Nivolumab
n=271 Participants
Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
|
Investigator Choice of Chemotherapy
n=270 Participants
Administered in 3-week cycles for up to 6 cycles:
Squamous:
* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
* paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.
|
Total
n=541 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 10.25 • n=39 Participants
|
63.4 years
STANDARD_DEVIATION 9.63 • n=41 Participants
|
63.1 years
STANDARD_DEVIATION 9.94 • n=35 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=39 Participants
|
122 Participants
n=41 Participants
|
209 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
184 Participants
n=39 Participants
|
148 Participants
n=41 Participants
|
332 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
141 Participants
n=39 Participants
|
139 Participants
n=41 Participants
|
280 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
126 Participants
n=39 Participants
|
128 Participants
n=41 Participants
|
254 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
228 Participants
n=39 Participants
|
242 Participants
n=41 Participants
|
470 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Asian
|
30 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
47 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)Population: All randomized participants with PD-L1 expression levels \>= 5%
Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.
Outcome measures
| Measure |
Nivolumab
n=211 Participants
Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
|
Investigator Choice of Chemotherapy
n=212 Participants
Administered in 3-week cycles for up to 6 cycles:
Squamous:
* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
* paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.
|
|---|---|---|
|
Progression-Free Survival in Participants With PD-L1 Expression >= 5%
|
4.21 Months
Interval 2.96 to 5.55
|
5.88 Months
Interval 5.42 to 6.93
|
SECONDARY outcome
Timeframe: From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)Population: All randomized participants
Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.
Outcome measures
| Measure |
Nivolumab
n=271 Participants
Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
|
Investigator Choice of Chemotherapy
n=270 Participants
Administered in 3-week cycles for up to 6 cycles:
Squamous:
* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
* paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.
|
|---|---|---|
|
Progression-Free Survival in All Randomized Participants
|
4.21 Months
Interval 3.06 to 5.52
|
5.82 Months
Interval 5.42 to 6.9
|
SECONDARY outcome
Timeframe: From date of randomization to date of death (up to approximately 89 months)Population: All randomized participants with PD-L1 expression \>= 5%
Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.
Outcome measures
| Measure |
Nivolumab
n=211 Participants
Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
|
Investigator Choice of Chemotherapy
n=212 Participants
Administered in 3-week cycles for up to 6 cycles:
Squamous:
* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
* paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.
|
|---|---|---|
|
Overall Survival in Participants With PD-L1 Expression >= 5%
|
14.36 Months
Interval 11.66 to 17.08
|
13.21 Months
Interval 10.81 to 17.28
|
SECONDARY outcome
Timeframe: From date of randomization to date of death (up to approximately 89 months)Population: All randomized participants
Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.
Outcome measures
| Measure |
Nivolumab
n=271 Participants
Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
|
Investigator Choice of Chemotherapy
n=270 Participants
Administered in 3-week cycles for up to 6 cycles:
Squamous:
* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
* paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.
|
|---|---|---|
|
Overall Survival in All Randomized Participants
|
13.73 Months
Interval 11.76 to 15.41
|
13.80 Months
Interval 11.01 to 16.99
|
SECONDARY outcome
Timeframe: From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months)Population: All randomized participants with PD-L1 expression \>= 5%
ORR was defined as the proportion of randomized participants who achieved a Best Overall Response (BOR) of CR or PR using the RECIST v1.1 criteria per Independent Radiology Review Committee (IRRC) assessment. BOR was defined as the best response designation recorded between the date of randomization and the date of objectively documented progression or start of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. For participants who continued treatment beyond progression, BOR was determined from response designations recorded up to the time of initial progression. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by \>=50% of previously involved sites from nadir.
Outcome measures
| Measure |
Nivolumab
n=211 Participants
Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
|
Investigator Choice of Chemotherapy
n=212 Participants
Administered in 3-week cycles for up to 6 cycles:
Squamous:
* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
* paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.
|
|---|---|---|
|
Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%
|
26.1 Percentage of participants
Interval 20.3 to 32.5
|
33.5 Percentage of participants
Interval 27.2 to 40.3
|
SECONDARY outcome
Timeframe: From date of randomization to week 12Population: All randomized participants
The Lung Cancer Symptom Score (LCSS) is a validated instrument designed to assess the impact of treatment on disease-related symptoms. It consists of 6 symptom-specific questions related to dyspnea, cough, fatigue, pain, hemoptysis and anorexia plus 3 summary items: symptom distress, interference with activity, and global HRQoL. The degree of impairment was recorded on a 100 mm visual analogue scale with scores from 0 to 100 with zero representing the best score. Disease-related symptom improvement rate by Week 12 is defined as the proportion of all randomized (all PD-L1+) participants who had 10 points or more decrease from baseline in average symptom burden index score at any time between randomization and Week 12.
Outcome measures
| Measure |
Nivolumab
n=271 Participants
Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
|
Investigator Choice of Chemotherapy
n=270 Participants
Administered in 3-week cycles for up to 6 cycles:
Squamous:
* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
* paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.
|
|---|---|---|
|
Disease-related Symptom Improvement Rate by Week 12
|
35.4 Percentage of participants
Interval 29.7 to 41.4
|
33.7 Percentage of participants
Interval 28.1 to 39.7
|
Adverse Events
Nivolumab
Serious events: 195 serious events
Other events: 245 other events
Deaths: 233 deaths
Investigator Choice of Chemotherapy
Serious events: 203 serious events
Other events: 252 other events
Deaths: 92 deaths
Post Chemotherapy Optional Nivolumab
Serious events: 110 serious events
Other events: 137 other events
Deaths: 136 deaths
Serious adverse events
| Measure |
Nivolumab
n=267 participants at risk
Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
|
Investigator Choice of Chemotherapy
n=263 participants at risk
Administered in 3-week cycles for up to 6 cycles:
Squamous:
* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
* paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.
|
Post Chemotherapy Optional Nivolumab
n=159 participants at risk
Participants from the Investigator Choice Arm who progressed during Post-Chemotherapy Phase could receive crossover nivolumab treatment after disease progression. These participants received Nivolumab 3 mg/kg IV infusion every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.1%
16/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
2/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.1%
3/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
7/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.5%
4/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.3%
6/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Acute coronary syndrome
|
1.1%
3/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.3%
6/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
3/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
2/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.5%
4/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
3/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure acute
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac tamponade
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
7/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.5%
4/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Pericarditis constrictive
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Sinus bradycardia
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Congenital, familial and genetic disorders
Tornwaldt cyst
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Adrenal insufficiency
|
1.5%
4/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.5%
4/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
2/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
2/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Cataract
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Exophthalmos
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Glaucoma
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Ophthalmic vein thrombosis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.5%
4/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Ascites
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Colitis
|
1.5%
4/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
3/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
7/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.3%
6/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.5%
4/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
4/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
5/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
4/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
5/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Catheter site pain
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Chest pain
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Death
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.0%
8/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
3/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
General physical health deterioration
|
1.5%
4/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.3%
6/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.5%
4/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Illness
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Localised oedema
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pain
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Performance status decreased
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
2.6%
7/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.4%
9/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.8%
6/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Sudden death
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholestasis
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatitis
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Hypersensitivity
|
1.1%
3/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Bronchitis
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Diverticulitis
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Infection
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Influenza
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Localised infection
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Norovirus infection
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pleural infection
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
7.9%
21/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.9%
26/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.0%
8/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia aspiration
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia bacterial
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Sepsis
|
1.9%
5/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
5/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
3/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Septic shock
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Skin infection
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Subcutaneous abscess
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
3/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
2/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Wound infection
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Kyphosis postoperative
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
1.9%
5/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
2.2%
6/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
2/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood bilirubin increased
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood creatinine increased
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
General physical condition abnormal
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Transaminases increased
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
4/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
5/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
3/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.1%
3/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
3/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
2/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
5/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.5%
4/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
2/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
3.0%
8/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioblastoma
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal metastasis
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
2/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
25.8%
69/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
36.1%
95/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
34.6%
55/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
1.5%
4/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
5/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
3/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.0%
8/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.8%
6/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
1.1%
3/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Extremity necrosis
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant
|
1.9%
5/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.5%
4/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Aphasia
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Epilepsy
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
IIIrd nerve paresis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Ischaemic stroke
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Malignant spinal cord compression
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Muscle spasticity
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Presyncope
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Seizure
|
1.5%
4/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Spinal cord compression
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Syncope
|
1.5%
4/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
VIth nerve paresis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Product Issues
Device occlusion
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Confusional state
|
1.1%
3/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Mental status changes
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Organic brain syndrome
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Psychotic disorder
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicide attempt
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Haematuria
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Oliguria
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal failure
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
3/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
7/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.2%
6/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.4%
9/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.1%
5/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal disorder
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
8/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
5/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
3/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.4%
9/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.5%
4/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
2/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.0%
8/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
11/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.1%
5/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.75%
2/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary microemboli
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
4/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
2/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Air embolism
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
1.1%
3/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Embolism
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.5%
4/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Hypotension
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Leriche syndrome
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Peripheral ischaemia
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.76%
2/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Vascular occlusion
|
0.00%
0/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Vein disorder
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Venous thrombosis
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Nivolumab
n=267 participants at risk
Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
|
Investigator Choice of Chemotherapy
n=263 participants at risk
Administered in 3-week cycles for up to 6 cycles:
Squamous:
* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
* paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.
|
Post Chemotherapy Optional Nivolumab
n=159 participants at risk
Participants from the Investigator Choice Arm who progressed during Post-Chemotherapy Phase could receive crossover nivolumab treatment after disease progression. These participants received Nivolumab 3 mg/kg IV infusion every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.
|
|---|---|---|---|
|
Vascular disorders
Hypotension
|
3.4%
9/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
14/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.0%
8/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.2%
54/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
54.0%
142/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
23.9%
38/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.37%
1/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.5%
17/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
5/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
20.5%
54/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.5%
4/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.9%
5/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.2%
40/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.5%
4/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypothyroidism
|
8.6%
23/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.7%
23/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.8%
14/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Lacrimation increased
|
1.1%
3/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
21/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.1%
35/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.2%
32/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.5%
12/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.1%
11/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.7%
23/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
9/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
24.3%
65/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
31.9%
84/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.1%
24/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
31.5%
84/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
31.2%
82/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
29/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
4.9%
13/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.6%
12/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.0%
8/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
19/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.9%
13/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
2/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
32.2%
86/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
56.7%
149/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.6%
36/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
4.9%
13/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.6%
20/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.1%
5/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
22.1%
59/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
29.3%
77/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.1%
16/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
9.7%
26/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.6%
41/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.2%
13/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Chest pain
|
3.4%
9/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.5%
25/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
9/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Chills
|
6.7%
18/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.8%
18/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.8%
6/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
40.4%
108/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
51.0%
134/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
29.6%
47/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Malaise
|
5.6%
15/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
14/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.1%
5/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Mucosal inflammation
|
2.6%
7/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.7%
23/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
3/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
9.4%
25/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
21/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.9%
11/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
13.1%
35/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.5%
67/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
13.2%
21/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pain
|
5.2%
14/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.6%
12/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
9/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
13.9%
37/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
20.9%
55/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
13.8%
22/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Bronchitis
|
4.9%
13/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.2%
19/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.3%
10/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
19/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.6%
20/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.3%
10/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
9.4%
25/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.7%
23/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
9/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.0%
24/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
24/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
9/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
5.2%
14/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.9%
13/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.5%
4/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
15/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
11/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.1%
5/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
11.6%
31/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.4%
30/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.2%
13/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
14.6%
39/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.6%
28/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.3%
10/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.2%
22/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.8%
18/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.4%
7/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood creatinine increased
|
4.9%
13/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.9%
34/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.7%
17/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.7%
10/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
14/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.5%
4/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Lymphocyte count decreased
|
6.7%
18/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.8%
18/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.1%
5/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Neutrophil count decreased
|
3.4%
9/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
16.3%
43/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.5%
4/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Platelet count decreased
|
4.5%
12/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.4%
38/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.63%
1/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Weight decreased
|
15.7%
42/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.1%
37/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.5%
12/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
White blood cell count decreased
|
2.6%
7/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
33/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.8%
6/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
34.1%
91/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
38.8%
102/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
23.3%
37/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.7%
10/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.2%
19/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.4%
7/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.1%
19/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.8%
18/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.3%
10/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.6%
15/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.2%
19/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.9%
11/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.5%
28/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.3%
27/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.9%
11/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.0%
24/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.8%
31/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.2%
13/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.0%
16/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.6%
49/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.9%
19/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.5%
28/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.1%
37/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.2%
13/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.2%
6/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.5%
17/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.8%
6/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.9%
53/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
17.9%
47/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
29/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.7%
42/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
23.6%
62/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.5%
23/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.4%
9/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
14/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.3%
10/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.4%
17/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.9%
26/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
9/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.7%
18/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.9%
13/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.1%
5/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.5%
28/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.6%
28/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.3%
10/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.6%
23/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.8%
31/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.9%
11/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
11.2%
30/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.6%
41/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
13.2%
21/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dysgeusia
|
5.2%
14/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.5%
25/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.4%
7/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
11.2%
30/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
19.0%
50/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.9%
19/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.9%
5/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
15/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.0%
8/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.6%
7/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
24/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.4%
7/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
6.4%
17/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.8%
18/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.5%
12/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Depression
|
5.2%
14/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.9%
13/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.5%
4/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
9.0%
24/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.2%
40/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.3%
18/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.8%
77/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
30.0%
79/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
23.3%
37/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.5%
12/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
21/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
3/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.8%
69/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
28.5%
75/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
23.9%
38/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.0%
8/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.4%
22/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.5%
4/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.4%
17/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.6%
20/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.0%
8/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.0%
8/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
15/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.1%
5/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
8/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.1%
16/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
9/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.5%
12/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.5%
17/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.4%
15/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.2%
30/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.5%
25/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.0%
8/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.4%
9/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.9%
26/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
3/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.2%
22/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.9%
26/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.8%
14/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.6%
39/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.8%
31/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.7%
17/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.6%
39/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.1%
37/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.6%
20/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.7%
18/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.6%
12/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.8%
6/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Hypertension
|
6.7%
18/267 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.2%
19/263 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.0%
8/159 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER