Trial Outcomes & Findings for Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma (NCT NCT01335399)
NCT ID: NCT01335399
Last Updated: 2022-09-30
Results Overview
PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause. The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Censoring rules applied: * Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy. * Participants who had an event (progression or death) \> 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event. * Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment. * Participants without any post-baseline tumor assessments were censored on the date of randomization
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
748 participants
Primary outcome timeframe
From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)
Results posted on
2022-09-30
Participant Flow
Participant milestones
| Measure |
E-Ld Cohort
Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
Ld Cohort
Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
|---|---|---|
|
Pre-treatment Period
STARTED
|
374
|
374
|
|
Pre-treatment Period
COMPLETED
|
371
|
371
|
|
Pre-treatment Period
NOT COMPLETED
|
3
|
3
|
|
Treatment Period
STARTED
|
371
|
371
|
|
Treatment Period
COMPLETED
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
371
|
371
|
Reasons for withdrawal
| Measure |
E-Ld Cohort
Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
Ld Cohort
Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
|---|---|---|
|
Pre-treatment Period
No longer meeting study criteria
|
0
|
1
|
|
Pre-treatment Period
Participant request to discontinue
|
0
|
1
|
|
Pre-treatment Period
Adverse event unrelated to study drug
|
0
|
1
|
|
Pre-treatment Period
Consent withdrawal
|
3
|
0
|
|
Treatment Period
Disease progression
|
117
|
145
|
|
Treatment Period
Adverse event unrelated to study drug
|
110
|
73
|
|
Treatment Period
Study drug toxicity
|
52
|
64
|
|
Treatment Period
Participant request to discontinue
|
30
|
22
|
|
Treatment Period
Other reasons
|
30
|
30
|
|
Treatment Period
Consent withdrawal
|
10
|
7
|
|
Treatment Period
Death
|
7
|
6
|
|
Treatment Period
Poor/Non-compliance
|
3
|
4
|
|
Treatment Period
Lost to Follow-up
|
2
|
2
|
|
Treatment Period
Maximum clinical benefit
|
1
|
1
|
|
Treatment Period
No longer meet study criteria
|
1
|
1
|
|
Treatment Period
Administrative reasons by Sponsor
|
8
|
16
|
Baseline Characteristics
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma
Baseline characteristics by cohort
| Measure |
E-Ld Cohort
n=374 Participants
Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
Ld Cohort
n=374 Participants
Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
Total
n=748 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.9 Years
STANDARD_DEVIATION 6.58 • n=5 Participants
|
73.1 Years
STANDARD_DEVIATION 6.70 • n=7 Participants
|
73.0 Years
STANDARD_DEVIATION 6.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
163 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
336 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
211 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
412 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
295 Participants
n=5 Participants
|
279 Participants
n=7 Participants
|
574 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
360 Participants
n=5 Participants
|
351 Participants
n=7 Participants
|
711 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
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)Population: All randomized participants
PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause. The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Censoring rules applied: * Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy. * Participants who had an event (progression or death) \> 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event. * Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment. * Participants without any post-baseline tumor assessments were censored on the date of randomization
Outcome measures
| Measure |
E-Ld Cohort
n=374 Participants
Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
Ld Cohort
n=374 Participants
Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
31.38 Months
Interval 26.18 to 36.8
|
29.47 Months
Interval 23.49 to 34.3
|
SECONDARY outcome
Timeframe: From randomization to primary completion date (approximately 8 years)Population: All randomized participants
ORR is defined as the percentage of participants with objective response among all randomized subjects. Participants with an objective response are those participants experiencing a partial response (PR) or better, based on Independent Review Committee (IRC) assessment, as per EBMT criteria.
Outcome measures
| Measure |
E-Ld Cohort
n=374 Participants
Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
Ld Cohort
n=374 Participants
Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
|---|---|---|
|
Objective Response Rate (ORR)
|
82.9 Percent of Participants
Interval 78.7 to 86.6
|
79.4 Percent of Participants
Interval 75.0 to 83.4
|
SECONDARY outcome
Timeframe: From randomization to the date of death (up to 8 years)Population: All randomized participants
Survival is defined as the time from randomization to the date of death. A participant who did not die had his or her survival duration censored at the date of last contact ('last known date alive").
Outcome measures
| Measure |
E-Ld Cohort
n=374 Participants
Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
Ld Cohort
n=374 Participants
Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
|---|---|---|
|
Overall Survival (OS)
|
60.42 Months
Interval 52.76 to 67.35
|
57.56 Months
Interval 48.95 to 66.56
|
SECONDARY outcome
Timeframe: From Baseline to End of Treatment (approximately 8 years)Population: All randomized participants
Pain severity (sensory dimension) and pain interference (reactive dimension, assessing the degree to which pain interferes with function) are measured using the Brief Pain Inventory- Short Form (BPI-SF). BPI-SF numeric rating scale goes from 0 (No pain) to 10 (Pain as bad as you can imagine).
Outcome measures
| Measure |
E-Ld Cohort
n=374 Participants
Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
Ld Cohort
n=374 Participants
Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
|---|---|---|
|
Mean Change From Baseline of Pain Severity Score and Pain Interference Score
Pain Severity
|
0.02 Rating score
Standard Deviation 2.645
|
-0.25 Rating score
Standard Deviation 2.721
|
|
Mean Change From Baseline of Pain Severity Score and Pain Interference Score
Pain Interference
|
0.33 Rating score
Standard Deviation 3.077
|
-0.18 Rating score
Standard Deviation 3.082
|
SECONDARY outcome
Timeframe: From randomization to the specified time-point (up to 5 years)Population: All randomized participants
PFS rate is defined as the percentage of participants experiencing PFS at the defined time-points.
Outcome measures
| Measure |
E-Ld Cohort
n=374 Participants
Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
Ld Cohort
n=374 Participants
Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
|---|---|---|
|
Progression Free Survival (PFS) Rate at Specific Time-points
1 year
|
0.77 Percent of participants
Interval 0.72 to 0.81
|
0.76 Percent of participants
Interval 0.71 to 0.8
|
|
Progression Free Survival (PFS) Rate at Specific Time-points
2 year
|
0.59 Percent of participants
Interval 0.53 to 0.64
|
0.55 Percent of participants
Interval 0.49 to 0.6
|
|
Progression Free Survival (PFS) Rate at Specific Time-points
3 year
|
0.46 Percent of participants
Interval 0.4 to 0.51
|
0.41 Percent of participants
Interval 0.35 to 0.46
|
|
Progression Free Survival (PFS) Rate at Specific Time-points
4 year
|
0.36 Percent of participants
Interval 0.31 to 0.41
|
0.33 Percent of participants
Interval 0.28 to 0.38
|
|
Progression Free Survival (PFS) Rate at Specific Time-points
5 year
|
0.26 Percent of participants
Interval 0.21 to 0.32
|
0.25 Percent of participants
Interval 0.2 to 0.3
|
Adverse Events
E-Ld Cohort
Serious events: 293 serious events
Other events: 364 other events
Deaths: 240 deaths
Ld Cohort
Serious events: 279 serious events
Other events: 365 other events
Deaths: 232 deaths
Serious adverse events
| Measure |
E-Ld Cohort
n=371 participants at risk
Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
Ld Cohort
n=371 participants at risk
Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Blood and lymphatic system disorders
Anaemia
|
3.2%
12/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
12/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
5/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haemolysis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Plasmacytosis
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.9%
7/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 unstable
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Aortic valve calcification
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Aortic valve incompetence
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.9%
22/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
12/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 thrombosis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Atrioventricular block
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Cardiac disorders
Bradycardia
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.9%
7/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
6/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Cardiac disorders
Cardiac failure
|
3.5%
13/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.9%
7/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Cardiac disorders
Cardiac failure acute
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Cardiac disorders
Cardiac failure chronic
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 septal hypertrophy
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 ventricular thrombosis
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cardiomyopathy
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cardiopulmonary failure
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Cardiac disorders
Cardiovascular disorder
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Congestive cardiomyopathy
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Coronary artery disease
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Left ventricular dysfunction
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Mitral valve incompetence
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.6%
6/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.3%
5/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Prinzmetal angina
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Cardiac disorders
Sinus arrest
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Cardiac disorders
Sinus node dysfunction
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Supraventricular tachycardia
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Systolic dysfunction
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Cardiac disorders
Tachycardia
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Torsade de pointes
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Corneal dystrophy
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Sudden hearing loss
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Vertigo
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Blindness transient
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Eye disorders
Cataract
|
2.7%
10/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
2.4%
9/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Eye disorders
Cataract cortical
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Epiretinal membrane
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Retinal detachment
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 lower
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Anal haemorrhage
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Anorectal varices haemorrhage
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Gastrointestinal disorders
Colitis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 ulcerative
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Gastrointestinal disorders
Constipation
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Diaphragmatic hernia
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
9/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
2.7%
10/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Diverticulum intestinal
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Gastrointestinal disorders
Enteritis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Enterovesical fistula
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Femoral hernia
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hiatus hernia
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Gastrointestinal disorders
Ileus
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Incarcerated inguinal hernia
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Incarcerated umbilical hernia
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Inguinal hernia
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Inguinal hernia strangulated
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 infarction
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Odynophagia
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 ulcer
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Oroantral fistula
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pneumatosis intestinalis
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Umbilical hernia
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Varices oesophageal
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Adverse drug reaction
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
General disorders
Asthenia
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
6/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.2%
8/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.3%
5/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Fat necrosis
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.3%
5/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
General disorders
Malaise
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
General disorders
Oedema peripheral
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
General disorders
Performance status decreased
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.1%
19/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.9%
7/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
General disorders
Sudden death
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Systemic inflammatory response syndrome
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Hepatobiliary disorders
Bile duct stone
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 chronic
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Hepatobiliary disorders
Gallbladder rupture
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hydrocholecystis
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Hepatobiliary disorders
Jaundice
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Drug hypersensitivity
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Abscess
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Appendicitis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Atypical pneumonia
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Fibula fracture
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 prostatitis
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Biliary sepsis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Bronchitis
|
4.9%
18/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
6/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bursitis infective
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.4%
9/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
2.2%
8/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 orbital
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Central nervous system infection
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Clostridial sepsis
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 colitis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Clostridium difficile infection
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dacryocystitis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.3%
5/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Escherichia infection
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.2%
8/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 clostridial
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 salmonella
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 viral
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
H1N1 influenza
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hepatitis E
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 disseminated
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 cyst
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Infectious pleural effusion
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.9%
7/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
6/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Intervertebral discitis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Large intestine infection
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Leishmaniasis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Liver abscess
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.4%
9/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
2.2%
8/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 listeria
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Metapneumovirus bronchiolitis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Metapneumovirus infection
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Orchitis
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Perirectal abscess
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Peritonitis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pharyngitis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Plague
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Pleural infection
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pneumococcal sepsis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
16.2%
60/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
12.9%
48/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.3%
5/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 fungal
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 influenzal
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 legionella
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 staphylococcal
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 streptococcal
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 viral
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Progressive multifocal leukoencephalopathy
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pseudomembranous colitis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Pyelonephritis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pyoderma
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 syncytial virus infection
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.2%
8/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Sepsis
|
4.0%
15/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
6/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
6/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.3%
5/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.0%
15/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
3.0%
11/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 bacterial
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 enterococcal
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Urosepsis
|
1.3%
5/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.3%
5/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Varicella zoster virus infection
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Viral infection
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Whipple's disease
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Wound infection staphylococcal
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Combined tibia-fibula fracture
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Fracture
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Comminuted fracture
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Extradural haematoma
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
2.2%
8/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Head injury
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.3%
5/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Medication error
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Injury, poisoning and procedural complications
Overdose
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pelvic fracture
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Rib fracture
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Shunt malfunction
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Skin laceration
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Stress fracture
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Subdural haematoma
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Tibia fracture
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Traumatic fracture
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Wrist fracture
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Investigations
Alanine aminotransferase increased
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bacterial test positive
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Investigations
Blood creatinine increased
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Influenza A virus test positive
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Influenza B virus test positive
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 abnormal
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Respiratory syncytial virus test positive
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Respirovirus test positive
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Investigations
Transaminases increased
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Viral test positive
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Alcohol intolerance
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.9%
7/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.3%
5/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 complication
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 metabolic decompensation
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.3%
5/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypervolaemia
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.3%
5/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 reactive
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.0%
11/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
2.4%
9/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bursitis
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Chondrocalcinosis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Chondrocalcinosis pyrophosphate
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Intervertebral disc protrusion
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Joint hyperextension
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 disorder
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Osteitis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Osteoarthritis
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 of jaw
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Acute lymphocytic leukaemia
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma metastatic
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Angiosarcoma
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Atypical fibroxanthoma
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.7%
10/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
2.7%
10/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Basosquamous carcinoma
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 neoplasm
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Bowen's disease
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Cholangiocarcinoma
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Gastric cancer
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Hepatic cancer
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Hepatocellular carcinoma
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Intraductal proliferative breast lesion
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Keratoacanthoma
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 squamous cell carcinoma
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Lip squamous cell carcinoma
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Myelodysplastic syndrome
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Nasal cavity cancer
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Pancreatic carcinoma
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Papilloma
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Plasma cell leukaemia
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Plasma cell myeloma
|
1.3%
5/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Plasmacytoma
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Prostate cancer
|
1.3%
5/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Rectosigmoid cancer
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Refractory anaemia with ringed sideroblasts
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Sebaceous carcinoma
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Spindle cell sarcoma
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.5%
13/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.9%
7/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 of head and neck
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 of skin
|
2.4%
9/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.9%
7/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 of the oral cavity
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Transitional cell carcinoma
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Nervous system disorders
Ataxia
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cerebellar haemorrhage
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 haemorrhage
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 ischaemia
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.2%
8/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.9%
7/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Nervous system disorders
Cognitive disorder
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Coma
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dementia
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 postural
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Nervous system disorders
Dysarthria
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Generalised tonic-clonic seizure
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Guillain-Barre syndrome
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haemorrhagic cerebral infarction
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haemorrhagic stroke
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Nervous system disorders
Headache
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Intracranial aneurysm
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Intracranial haematoma
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 cerebral infarction
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lethargy
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Nervous system disorders
Loss of consciousness
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Memory impairment
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Migraine
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Myelopathy
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Normal pressure hydrocephalus
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Nervous system disorders
Presyncope
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Sciatica
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Somnolence
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Nervous system disorders
Syncope
|
1.9%
7/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.3%
5/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Nervous system disorders
Transient aphasia
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Nervous system disorders
Transient ischaemic attack
|
1.6%
6/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Psychiatric disorders
Confusional state
|
1.3%
5/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.3%
5/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Delusional disorder, unspecified type
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Psychiatric disorders
Depression
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Psychiatric disorders
Mental status changes
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Psychiatric disorders
Psychotic disorder
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.4%
20/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
20/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Calculus urinary
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Chronic kidney disease
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
End stage renal disease
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Renal and urinary disorders
Haematuria
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Myeloma cast nephropathy
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Nephrolithiasis
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.7%
10/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.9%
7/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 impairment
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 injury
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 tubular necrosis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Renal and urinary disorders
Urinary retention
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bronchiectasis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bronchospasm
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.9%
7/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.5%
13/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
2.2%
8/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
5/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 congestion
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.2%
12/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
4.0%
15/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 depression
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
4/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Restrictive pulmonary disease
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Sinus disorder
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Vocal cord disorder
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Actinic keratosis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Angioedema
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cold sweat
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cutaneous vasculitis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 bullous
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 exfoliative generalised
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Diabetic foot
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Exfoliative rash
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Purpura
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 ulcer
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Stasis dermatitis
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Arteriosclerosis
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.4%
9/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
2.7%
10/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Vascular disorders
Embolism
|
0.81%
3/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Vascular disorders
Embolism venous
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Vascular disorders
Haematoma
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.9%
7/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Malignant hypertension
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Superficial vein thrombosis
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Thrombophlebitis
|
0.54%
2/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
0.27%
1/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 |
E-Ld Cohort
n=371 participants at risk
Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
Ld Cohort
n=371 participants at risk
Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
41.2%
153/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
160/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.2%
23/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
10.0%
37/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
25.1%
93/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
31.5%
117/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
17.8%
66/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
18.6%
69/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.5%
28/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
6.7%
25/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Eye disorders
Cataract
|
16.4%
61/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
15.1%
56/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Vision blurred
|
7.5%
28/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
28/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Gastrointestinal disorders
Abdominal pain
|
13.5%
50/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
13.7%
51/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.9%
33/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
7.8%
29/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
38.3%
142/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
38.8%
144/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
51.8%
192/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
48.5%
180/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Gastrointestinal disorders
Dry mouth
|
7.5%
28/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
26/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.6%
43/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
32/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.7%
10/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
5.1%
19/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
31.5%
117/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
29.1%
108/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Gastrointestinal disorders
Toothache
|
6.5%
24/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
4.0%
15/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
18.6%
69/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
13.5%
50/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
23.7%
88/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
19.7%
73/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.5%
24/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
32/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
General disorders
Chills
|
9.4%
35/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
2.4%
9/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
49.3%
183/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
50.7%
188/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
10.8%
40/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
28/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.7%
21/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
2.2%
8/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.4%
20/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
5.1%
19/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.6%
17/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
5.1%
19/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
43.9%
163/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
49.1%
182/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
General disorders
Pain
|
6.5%
24/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
5.1%
19/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Peripheral swelling
|
6.5%
24/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
6.5%
24/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
29.9%
111/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
20.8%
77/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
12.4%
46/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
14.0%
52/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.7%
21/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
26/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.5%
13/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
20/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.2%
23/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
4.9%
18/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.8%
14/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
20/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Infections and infestations
Nasopharyngitis
|
16.2%
60/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
16.7%
62/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 herpes
|
6.2%
23/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
3.0%
11/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.9%
33/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
6.2%
23/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
10.2%
38/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
9.2%
34/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.2%
23/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
4.6%
17/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
22.1%
82/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
22.6%
84/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
15.6%
58/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
15.1%
56/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Contusion
|
12.7%
47/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
14.3%
53/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Injury, poisoning and procedural complications
Fall
|
8.9%
33/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
32/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Skin abrasion
|
6.5%
24/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
3.5%
13/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Skin laceration
|
5.1%
19/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
6.2%
23/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.9%
18/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
27/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.6%
17/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
21/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
15.1%
56/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
19.4%
72/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Glomerular filtration rate decreased
|
5.4%
20/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
4.6%
17/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Investigations
Neutrophil count decreased
|
3.0%
11/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
28/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Investigations
Platelet count decreased
|
3.2%
12/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
20/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
21.3%
79/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
17.8%
66/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
27.0%
100/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
23.2%
86/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.7%
25/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
22/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
32.3%
120/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
18.6%
69/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.5%
24/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
21/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
19.7%
73/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
20.2%
75/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
22.6%
84/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
24.5%
91/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.1%
41/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
6.2%
23/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.3%
27/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
4.6%
17/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.4%
20/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
16/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
29.9%
111/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
32.6%
121/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
35.8%
133/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
36.7%
136/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
15.6%
58/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
15.4%
57/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Joint swelling
|
5.1%
19/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
4.9%
18/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
22.6%
84/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
22.4%
83/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
12.1%
45/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
14.0%
52/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
13.2%
49/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
13.5%
50/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.5%
28/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
21/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
22/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
4.6%
17/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
30/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
10.0%
37/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.5%
76/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
21.0%
78/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
5.1%
19/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
12/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
4.0%
15/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
6.2%
23/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
22.6%
84/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
18.3%
68/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Nervous system disorders
Dysgeusia
|
7.0%
26/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
3.5%
13/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
16.4%
61/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
13.5%
50/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.5%
24/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
6.7%
25/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Memory impairment
|
7.3%
27/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
4.0%
15/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.1%
41/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
12.9%
48/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Nervous system disorders
Paraesthesia
|
10.8%
40/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
12.1%
45/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.4%
57/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
15.9%
59/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.9%
18/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
20/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Nervous system disorders
Taste disorder
|
6.5%
24/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
27/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Tremor
|
16.4%
61/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
14.8%
55/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Agitation
|
5.7%
21/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
4.6%
17/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.9%
44/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
28/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Psychiatric disorders
Confusional state
|
10.0%
37/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
32/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Psychiatric disorders
Depression
|
11.3%
42/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
31/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Psychiatric disorders
Insomnia
|
26.4%
98/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
25.9%
96/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Mood altered
|
6.7%
25/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
4.6%
17/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dysuria
|
4.3%
16/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
5.1%
19/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pollakiuria
|
3.8%
14/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
5.1%
19/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
32.3%
120/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
28.6%
106/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
12.1%
45/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
27/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
23.5%
87/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
25.1%
93/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.5%
24/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
4.9%
18/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.3%
27/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
4.9%
18/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.0%
26/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
26/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.9%
33/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
20/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.3%
27/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
22/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.1%
19/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
21/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hyperhidrosis
|
9.7%
36/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
26/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Night sweats
|
6.5%
24/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
4.0%
15/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.5%
39/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
11.6%
43/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
24.3%
90/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
23.2%
86/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 lesion
|
5.1%
19/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
4.6%
17/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.4%
20/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
26/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Flushing
|
5.1%
19/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
4.6%
17/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
14.6%
54/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
11.9%
44/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
17.0%
63/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
|
11.9%
44/371 • All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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