Trial Outcomes & Findings for Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (NCT NCT02741570)
NCT ID: NCT02741570
Last Updated: 2023-09-21
Results Overview
Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
947 participants
Primary outcome timeframe
From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)
Results posted on
2023-09-21
Participant Flow
947 participants randomized to receive study treatment. 909 participants received study treatment.
Participant milestones
| Measure |
Nivolumab + Ipilimumab
Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
|
EXTREME Regimen
Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
|
|---|---|---|
|
Pre-Treatment Period
STARTED
|
472
|
475
|
|
Pre-Treatment Period
COMPLETED
|
468
|
441
|
|
Pre-Treatment Period
NOT COMPLETED
|
4
|
34
|
|
Treatment Period
STARTED
|
468
|
441
|
|
Treatment Period
COMPLETED
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
468
|
441
|
Reasons for withdrawal
| Measure |
Nivolumab + Ipilimumab
Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
|
EXTREME Regimen
Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
|
|---|---|---|
|
Pre-Treatment Period
Other reasons
|
0
|
3
|
|
Pre-Treatment Period
Participant no longer meets study criteria
|
3
|
6
|
|
Pre-Treatment Period
Poor/non-compliance
|
0
|
1
|
|
Pre-Treatment Period
Lost to Follow-up
|
0
|
2
|
|
Pre-Treatment Period
Participant withdrew consent
|
0
|
18
|
|
Pre-Treatment Period
Participant request to discontinue study treatment
|
0
|
2
|
|
Pre-Treatment Period
Adverse event unrelated to study drug
|
1
|
0
|
|
Pre-Treatment Period
Death
|
0
|
1
|
|
Pre-Treatment Period
Disease progression
|
0
|
1
|
|
Treatment Period
Other reasons
|
47
|
12
|
|
Treatment Period
Poor/non-compliance
|
0
|
2
|
|
Treatment Period
Maximum clinical benefit
|
4
|
6
|
|
Treatment Period
Lost to Follow-up
|
1
|
3
|
|
Treatment Period
Participant withdrew consent
|
9
|
13
|
|
Treatment Period
Participant request to discontinue treatment
|
8
|
23
|
|
Treatment Period
Adverse event unrelated to study drug
|
41
|
26
|
|
Treatment Period
Death
|
9
|
7
|
|
Treatment Period
Study drug toxicity
|
55
|
47
|
|
Treatment Period
Disease progression
|
294
|
301
|
|
Treatment Period
Administrative reason by sponsor
|
0
|
1
|
Baseline Characteristics
Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Baseline characteristics by cohort
| Measure |
Nivolumab + Ipilimumab
n=472 Participants
Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
|
EXTREME Regimen
n=475 Participants
Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
|
Total
n=947 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.4 Years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
60.9 Years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
60.6 Years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Age, Customized
< 65
|
310 Participants
n=5 Participants
|
295 Participants
n=7 Participants
|
605 Participants
n=5 Participants
|
|
Age, Customized
>= 65 AND < 75
|
134 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
|
Age, Customized
>= 75 AND < 85
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Age, Customized
>= 85
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
380 Participants
n=5 Participants
|
397 Participants
n=7 Participants
|
777 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
40 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
199 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
406 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
233 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
458 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
58 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
379 Participants
n=5 Participants
|
401 Participants
n=7 Participants
|
780 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)Population: All randomized PD-L1 CPS \>= 20 participants
Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=185 Participants
Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
|
EXTREME Regimen
n=178 Participants
Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
|
|---|---|---|
|
Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20
|
17.58 Months
Interval 13.77 to 21.98
|
14.59 Months
Interval 12.32 to 15.97
|
PRIMARY outcome
Timeframe: From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)Population: All randomized participants
Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=472 Participants
Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
|
EXTREME Regimen
n=475 Participants
Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
|
|---|---|---|
|
Overall Survival (OS) in All Randomized Participants
|
13.90 Months
Interval 12.12 to 15.77
|
13.50 Months
Interval 12.55 to 15.21
|
SECONDARY outcome
Timeframe: From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months)Population: All randomized PD-L1 CPS ≥ 1 participants
Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=355 Participants
Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
|
EXTREME Regimen
n=372 Participants
Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
|
|---|---|---|
|
Overall Survival (OS) in Randomized Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥ 1
|
15.67 Months
Interval 13.7 to 18.79
|
13.24 Months
Interval 11.07 to 14.59
|
SECONDARY outcome
Timeframe: From randomization to disease progression or death (Up to approximately 65 months)Population: All randomized participants and randomized PD-L1 CPS \>= 20 participants
PFS is defined as the time between the date of randomization and the date of first documented tumor progression, based on Blinded Independent Central Review (BICR) assessments (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria), or death due to any cause, whichever occurs first. Participants who neither progress nor die will be censored on the date of their last tumor assessment. Participants who receive subsequent anti-cancer therapy prior to documented progression, will be censored on the date of their last tumor assessment prior to subsequent therapy. (Based on Kaplan-Meier Estimates) Progression is defined as at least a 20% increase in the sum of diameters of target lesions, in addition the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=472 Participants
Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
|
EXTREME Regimen
n=475 Participants
Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
|
|---|---|---|
|
Progression Free Survival (PFS)
Randomized participants
|
3.29 Months
Interval 2.83 to 4.17
|
6.77 Months
Interval 5.78 to 7.0
|
|
Progression Free Survival (PFS)
Randomized PD-L1 CPS >= 20 participants
|
5.39 Months
Interval 3.09 to 6.93
|
6.97 Months
Interval 5.78 to 8.67
|
SECONDARY outcome
Timeframe: From randomization up to approximately 65 monthsPopulation: All randomized participants and randomized PD-L1 CPS \>= 20 participants
Objective Response Rate (ORR) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria by blinded independent central review (BICR) assessment. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=472 Participants
Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
|
EXTREME Regimen
n=475 Participants
Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
|
|---|---|---|
|
Objective Response Rate (ORR)
Randomized PD-L1 CPS >= 20 participants
|
34.1 Percent
Interval 27.3 to 41.4
|
35.4 Percent
Interval 28.4 to 42.9
|
|
Objective Response Rate (ORR)
All randomized participants
|
24.2 Percent
Interval 20.4 to 28.3
|
37.1 Percent
Interval 32.7 to 41.6
|
SECONDARY outcome
Timeframe: From randomization to the first documented response (CR or PR) and progression (up to approximately 65 months)Population: All randomized participants and randomized PD-L1 CPS \>= 20 participants with a BOR response of CR or PR
The time between the first documented response (Complete response (CR) or partial response (PR)) and progression or death, per RECIST 1.1 by blinded independent central review (BICR) assessment. (Based on Kaplan-Meier Estimates) Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=114 Participants
Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
|
EXTREME Regimen
n=176 Participants
Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
|
|---|---|---|
|
Duration of Objective Response (DOR)
All randomized participants
|
16.59 Months
Interval 9.69 to 29.4
|
5.88 Months
Interval 5.45 to 6.97
|
|
Duration of Objective Response (DOR)
Randomized PD-L1 CPS >= 20 participants
|
33.51 Months
Interval 12.12 to
Insufficient number of participants with events
|
6.97 Months
Interval 5.65 to 10.12
|
POST_HOC outcome
Timeframe: From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months)Population: All randomized PD-L1 CPS \>= 20 participants
Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=185 Participants
Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
|
EXTREME Regimen
n=178 Participants
Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
|
|---|---|---|
|
Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20 - Extended Collection
|
17.74 Months
Interval 13.77 to 21.98
|
14.59 Months
Interval 12.32 to 15.97
|
POST_HOC outcome
Timeframe: From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months)Population: All randomized participants
Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=472 Participants
Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
|
EXTREME Regimen
n=475 Participants
Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
|
|---|---|---|
|
Overall Survival (OS) in All Randomized Participants - Extended Collection
|
13.90 Months
Interval 12.12 to 15.77
|
13.50 Months
Interval 12.48 to 15.11
|
Adverse Events
Nivolumab + Ipilimumab
Serious events: 313 serious events
Other events: 420 other events
Deaths: 388 deaths
EXTREME Regimen
Serious events: 290 serious events
Other events: 429 other events
Deaths: 406 deaths
Serious adverse events
| Measure |
Nivolumab + Ipilimumab
n=468 participants at risk
Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
|
EXTREME Regimen
n=441 participants at risk
Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.1%
18/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bone marrow failure
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cytopenia
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 bone marrow aplasia
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.3%
6/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.4%
24/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Iron deficiency anaemia
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lymphadenopathy mediastinal
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Angina pectoris
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Arrhythmia
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.85%
4/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cardio-respiratory arrest
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cardiogenic shock
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Palpitations
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Pericarditis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Tracheo-oesophageal fistula
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.85%
4/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Adrenocorticotropic hormone deficiency
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Autoimmune thyroiditis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hyperthyroidism
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypophysitis
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypopituitarism
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Immune-mediated hypophysitis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Inappropriate antidiuretic hormone secretion
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lymphocytic hypophysitis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Secondary adrenocortical insufficiency
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Corneal perforation
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Alcoholic pancreatitis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Autoimmune colitis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.1%
10/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cyclic vomiting syndrome
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
9/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.8%
8/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.7%
8/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
10/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Gastric ulcer
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 erosive
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haematemesis
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.64%
3/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Mechanical ileus
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Melaena
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Mesenteric haematoma
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Mouth haemorrhage
|
0.64%
3/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.91%
4/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Oral cavity fistula
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pancreatic failure
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pancreatic pseudocyst
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
6/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Swollen tongue
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.64%
3/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.85%
4/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.91%
4/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Complication associated with device
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Disease progression
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Face oedema
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.85%
4/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
6/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Inflammation
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Influenza like illness
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lithiasis
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 haemorrhage
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.6%
7/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.64%
3/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pneumatosis
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.85%
4/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
9/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Stenosis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 cardiac death
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.5%
7/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.8%
8/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Suprapubic pain
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Swelling face
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Ulcer haemorrhage
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.85%
4/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.64%
3/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cholecystocholangitis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.64%
3/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Anaphylactic shock
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Infusion related hypersensitivity reaction
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Abscess neck
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Actinomycosis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Arthritis infective
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Bacteraemia
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bacterial infection
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bacterial sepsis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Candida infection
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Catheter site infection
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
5/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.91%
4/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cystitis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Device related infection
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Device related sepsis
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Emphysematous cystitis
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Enterobacter sepsis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Epiglottitis
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Febrile infection
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Fungal infection
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Gastrointestinal infection
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 zoster
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 zoster oticus
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Impetigo
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Infected fistula
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.64%
3/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Infective spondylitis
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Laryngitis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lung abscess
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Mediastinitis
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Medical device site infection
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Meningitis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Mucosal infection
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Neutropenic infection
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Neutropenic sepsis
|
0.64%
3/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 infection
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Otitis externa
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Paronychia
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Periorbital cellulitis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pleurisy viral
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pneumocystis jirovecii pneumonia
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.3%
25/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.0%
31/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.7%
8/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.6%
7/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 cytomegaloviral
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 klebsiella
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 necrotising
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pseudomonas infection
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.64%
3/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.1%
10/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
10/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.64%
3/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Sialoadenitis
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Sinusitis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Soft tissue infection
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Staphylococcal bacteraemia
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Staphylococcal infection
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Staphylococcal sepsis
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Stoma site infection
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Streptococcal bacteraemia
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Tuberculosis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.64%
3/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 access site cellulitis
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 access site infection
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Accidental overdose
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Device placement issue
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Facial bones fracture
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Post procedural complication
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Post procedural haemorrhage
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 injury
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Stoma site inflammation
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Stoma site ulcer
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Tracheal haemorrhage
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Tracheal obstruction
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Tracheostomy malfunction
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Unintentional medical device removal
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Wound dehiscence
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Wound necrosis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Amylase increased
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hepatic enzyme increased
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lipase increased
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Liver function test increased
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Platelet count decreased
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.64%
3/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.91%
4/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
7/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.91%
4/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Electrolyte depletion
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Electrolyte imbalance
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
5/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Feeding disorder
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Gout
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hyperamylasaemia
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.5%
7/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hyperlipasaemia
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.6%
7/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.64%
3/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.91%
4/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.64%
3/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Tumour lysis syndrome
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Type 1 diabetes mellitus
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Arthritis
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Flank pain
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Gouty arthritis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haematoma muscle
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Immobilisation syndrome
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Jaw fistula
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 pain
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Rhabdomyolysis
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Rotator cuff syndrome
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Bladder cancer
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Infected neoplasm
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Laryngeal cancer
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Lentigo maligna
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
21.6%
101/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.7%
100/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Metastatic squamous cell carcinoma
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.85%
4/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Oesophageal carcinoma
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Oncologic complication
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Skin cancer
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Small cell lung cancer
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Squamous cell carcinoma
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
4.5%
21/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
9/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Carotid artery stenosis
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
5/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Complex regional pain syndrome
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Encephalopathy
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hemiparesis
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypotonia
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lumbar radiculopathy
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Metabolic encephalopathy
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Paraparesis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 dislocation
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Completed suicide
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Delirium tremens
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Eating disorder
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hallucination
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Mania
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.6%
7/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Anuria
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cystitis noninfective
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Nephritis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Nephropathy
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Ureterolithiasis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 pulmonary oedema
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 distress syndrome
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Asphyxia
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bronchopneumopathy
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.0%
14/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 dyspnoea
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 obstruction
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 oedema
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 stenosis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lower respiratory tract congestion
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 disorder
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 sleep apnoea syndrome
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pharyngeal haemorrhage
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
7/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pneumomediastinum
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
7/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.5%
7/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.6%
7/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 arrest
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 disorder
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 distress
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Tracheal fistula
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Tracheal stenosis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pemphigoid
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pemphigus
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Psoriasis
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 erythematous
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Subcutaneous emphysema
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Arterial haemorrhage
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haemorrhage
|
0.64%
3/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.43%
2/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.68%
3/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypovolaemic shock
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Internal haemorrhage
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Orthostatic hypotension
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 occlusion
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Shock haemorrhagic
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.23%
1/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Thrombosis
|
0.00%
0/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 rupture
|
0.21%
1/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 + Ipilimumab
n=468 participants at risk
Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
|
EXTREME Regimen
n=441 participants at risk
Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
21.8%
102/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
43.1%
190/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.3%
6/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.9%
35/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lymphopenia
|
3.6%
17/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
25/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.4%
11/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
29.7%
131/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.5%
7/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
24.7%
109/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.85%
4/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
27/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hyperthyroidism
|
8.5%
40/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.45%
2/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
18.4%
86/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.3%
19/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.3%
34/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
36/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.3%
95/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
35.6%
157/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
22.2%
104/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
32.0%
141/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.6%
12/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.6%
29/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.1%
52/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
49/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
21.6%
101/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
51.2%
226/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.1%
24/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
104/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
12.2%
57/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
27.4%
121/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
15.6%
73/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
24.0%
106/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
26.3%
123/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
34.9%
154/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.8%
27/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
31.1%
137/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.4%
30/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.6%
29/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.6%
26/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
15/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
10.5%
49/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.4%
46/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Folliculitis
|
1.3%
6/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
33/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.1%
19/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.6%
29/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Paronychia
|
1.9%
9/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
21.5%
95/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.8%
41/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
25/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.6%
26/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.3%
19/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.5%
35/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.2%
23/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Amylase increased
|
6.8%
32/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.1%
18/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.3%
39/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.1%
18/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.8%
27/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.3%
19/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.6%
17/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
34/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lipase increased
|
10.7%
50/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.3%
19/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.1%
19/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.0%
66/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.5%
7/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
13.6%
60/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
12.2%
57/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.4%
81/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
12/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
36/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
15.6%
73/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
26.1%
115/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
5/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
26/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.6%
31/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.2%
14/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.1%
24/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.5%
20/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.1%
33/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
26/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.8%
13/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.2%
45/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.8%
27/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
21.1%
93/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.3%
34/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.1%
146/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.3%
39/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.9%
35/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.1%
10/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
34/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
12.4%
58/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
21/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
26/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
21/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Neck pain
|
8.1%
38/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.6%
38/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.3%
20/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.3%
32/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.4%
30/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.0%
31/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.1%
10/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
34/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.5%
35/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
37/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
13.5%
63/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
34/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
12.6%
59/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.0%
53/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
5/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.0%
31/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.3%
6/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
40/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dermatitis acneiform
|
4.9%
23/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
147/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.5%
35/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
79/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
18.8%
88/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.6%
38/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
19.2%
90/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
40.1%
177/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.85%
4/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.7%
65/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.8%
13/468 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
25/441 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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