Trial Outcomes & Findings for Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk (NCT NCT03315143)
NCT ID: NCT03315143
Last Updated: 2022-10-28
Results Overview
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
10584 participants
Primary outcome timeframe
Up to 30 months
Results posted on
2022-10-28
Participant Flow
Participants took part in the study at 723 study centers in North America, Latin America, Western Europe, Eastern Europe, and the Rest of the World from 19 December 2017 to 08 July 2020.
Participants with a diagnosis of Type 2 diabetes (T2D), CV risk factors, and moderately impaired renal function were enrolled equally in 1 of 2 treatment groups, sotagliflozin or placebo.
Participant milestones
| Measure |
Sotagliflozin
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.
|
Placebo
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
5292
|
5292
|
|
Overall Study
Randomized and Treated
|
5291
|
5286
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5292
|
5292
|
Reasons for withdrawal
| Measure |
Sotagliflozin
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.
|
Placebo
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months.
|
|---|---|---|
|
Overall Study
Death
|
240
|
246
|
|
Overall Study
Withdrawal by Subject
|
57
|
68
|
|
Overall Study
Site Terminated by Sponsor
|
256
|
282
|
|
Overall Study
Study Terminated by Sponsor
|
4723
|
4664
|
|
Overall Study
Reason not Specified
|
16
|
32
|
Baseline Characteristics
Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
Baseline characteristics by cohort
| Measure |
Sotagliflozin
n=5292 Participants
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.
|
Placebo
n=5292 Participants
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months.
|
Total
n=10584 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
68.2 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
68.3 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2347 Participants
n=5 Participants
|
2407 Participants
n=7 Participants
|
4754 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2945 Participants
n=5 Participants
|
2885 Participants
n=7 Participants
|
5830 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1671 Participants
n=5 Participants
|
1678 Participants
n=7 Participants
|
3349 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3593 Participants
n=5 Participants
|
3581 Participants
n=7 Participants
|
7174 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
205 Participants
n=5 Participants
|
216 Participants
n=7 Participants
|
421 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
317 Participants
n=5 Participants
|
365 Participants
n=7 Participants
|
682 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
25 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
176 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
363 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4383 Participants
n=5 Participants
|
4329 Participants
n=7 Participants
|
8712 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
129 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
57 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 monthsPopulation: ITT population included all randomized participants analyzed according to the treatment group allocated by randomization.
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Outcome measures
| Measure |
Sotagliflozin
n=5292 Participants
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.
|
Placebo
n=5292 Participants
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months.
|
|---|---|---|
|
Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)
|
5.6 events per 100-person years
|
7.5 events per 100-person years
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: ITT population included all randomized participants analyzed according to the treatment group allocated by randomization.
Combined endpoint of the total occurrences (first and potentially subsequent) of HHF and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Outcome measures
| Measure |
Sotagliflozin
n=5292 Participants
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.
|
Placebo
n=5292 Participants
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months.
|
|---|---|---|
|
Total Number of Occurrences of HHF and Urgent HF Visits
|
3.5 events per 100-person years
|
5.1 events per 100-person years
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: ITT population included all randomized participants analyzed according to the treatment group allocated by randomization.
Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Outcome measures
| Measure |
Sotagliflozin
n=5292 Participants
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.
|
Placebo
n=5292 Participants
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months.
|
|---|---|---|
|
Number of Deaths From Cardiovascular Causes
|
2.2 events per 100-person years
|
2.4 events per 100-person years
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: ITT population included all randomized participants analyzed according to the treatment group allocated by randomization.
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, non-fatal stroke, and non-fatal myocardial infarction after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Outcome measures
| Measure |
Sotagliflozin
n=5292 Participants
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.
|
Placebo
n=5292 Participants
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months.
|
|---|---|---|
|
Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke
|
7.6 events per 100-person years
|
10.4 events per 100-person years
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: ITT population included all randomized participants analyzed according to the treatment group allocated by randomization.
Combined endpoint of the total number of occurrences (first and potentially subsequent) after randomization of HHF, urgent HF visits, CV Death, and HF while hospitalized. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Outcome measures
| Measure |
Sotagliflozin
n=5292 Participants
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.
|
Placebo
n=5292 Participants
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months.
|
|---|---|---|
|
Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized
|
6.4 events per 100-person years
|
8.3 events per 100-person years
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: ITT population included all randomized participants analyzed according to the treatment group allocated by randomization.
Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Outcome measures
| Measure |
Sotagliflozin
n=5292 Participants
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.
|
Placebo
n=5292 Participants
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months.
|
|---|---|---|
|
Number of Occurrences After Randomization of the Composite of Sustained ≥50% Decrease in Estimated Glomerular Filtration Rate (eGFR) From Baseline (for ≥30 Days), Chronic Dialysis, Renal Transplant, or Sustained eGFR <15 mL/Min/1.73 m^2 (for ≥30 Days)
|
0.5 events per 100-person years
|
0.7 events per 100-person years
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: ITT population included all randomized participants analyzed according to the treatment group allocated by randomization.
Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Outcome measures
| Measure |
Sotagliflozin
n=5292 Participants
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.
|
Placebo
n=5292 Participants
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months.
|
|---|---|---|
|
Number of Deaths From Any Cause
|
3.5 events per 100-person years
|
3.5 events per 100-person years
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: ITT population included all randomized participants analyzed according to the treatment group allocated by randomization.
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Outcome measures
| Measure |
Sotagliflozin
n=5292 Participants
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.
|
Placebo
n=5292 Participants
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months.
|
|---|---|---|
|
Total Number of Occurrences of CV Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
|
4.8 events per 100-person years
|
6.3 events per 100-person years
|
Adverse Events
Sotagliflozin
Serious events: 1236 serious events
Other events: 705 other events
Deaths: 246 deaths
Placebo
Serious events: 1331 serious events
Other events: 609 other events
Deaths: 246 deaths
Serious adverse events
| Measure |
Sotagliflozin
n=5291 participants at risk
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.
|
Placebo
n=5286 participants at risk
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Viral infection
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Viral myocarditis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Urinary tract infection
|
0.15%
8/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.19%
10/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.17%
9/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.25%
13/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Urinary tract infection fungal
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Urosepsis
|
0.23%
12/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.19%
10/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Vestibular neuronitis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Suspected COVID-19
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Tracheitis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Tracheobronchitis
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Systemic infection
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Systemic viral infection
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Bacterial sepsis
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.13%
7/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Bronchitis bacterial
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.09%
5/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
COVID-19
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.11%
6/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
COVID-19 pneumonia
|
0.11%
6/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.09%
5/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Campylobacter colitis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Cellulitis
|
0.42%
22/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.32%
17/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Chronic hepatitis B
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Cryptosporidiosis infection
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Cutaneous leishmaniasis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Cystitis
|
0.11%
6/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Cystitis bacterial
|
0.13%
7/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.15%
8/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Cystitis escherichia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Cystitis klebsiella
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Dengue haemorrhagic fever
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Dermo-hypodermitis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Diabetic foot infection
|
0.17%
9/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Diabetic gangrene
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Diverticulitis
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Dysentery
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Endocarditis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Erysipelas
|
0.11%
6/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.19%
10/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Fournier's gangrene
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Fungaemia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Gangrene
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.15%
8/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Gastroenteritis
|
0.34%
18/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.19%
10/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Gastroenteritis viral
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Genital abscess
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Groin abscess
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Groin infection
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Herpes zoster
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Impetigo
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Infected cyst
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Infected skin ulcer
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Infection
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Influenza
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.13%
7/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Injection site abscess
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Intestinal fistula infection
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Keratitis bacterial
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Klebsiella sepsis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Liver abscess
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Localised infection
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Ludwig angina
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Mastitis bacterial
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Mastoiditis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Meningoencephalitis bacterial
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Metapneumovirus infection
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Myocarditis infectious
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Necrotising fasciitis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Nephritis bacterial
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Ophthalmic herpes simplex
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Orchitis
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Osteomyelitis
|
0.17%
9/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.15%
8/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Osteomyelitis acute
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Osteomyelitis chronic
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Otitis externa
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Otitis media
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Otitis media bacterial
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Ovarian abscess
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Paronychia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Peptic ulcer helicobacter
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Peritonitis
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Periumbilical abscess
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Pneumonia
|
0.70%
37/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
1.1%
57/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Pneumonia adenoviral
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Pneumonia bacterial
|
0.32%
17/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.74%
39/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Pneumonia haemophilus
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Pneumonia influenzal
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Pneumonia streptococcal
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Pneumonia viral
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Post procedural pneumonia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Postoperative wound infection
|
0.11%
6/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Psoas abscess
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Pulmonary sepsis
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Pyelitis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Pyelonephritis
|
0.19%
10/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.19%
10/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Pyelonephritis acute
|
0.13%
7/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Pyelonephritis chronic
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Q fever
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Renal abscess
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Respiratory tract infection
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Scrotal abscess
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Sepsis
|
0.25%
13/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.23%
12/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Septic shock
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Sinusitis aspergillus
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Skin infection
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Soft tissue infection
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Subcutaneous abscess
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Subdiaphragmatic abscess
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Vulval cellulitis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Aortic dissection
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Aortic stenosis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Arterial haemorrhage
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Circulatory collapse
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Deep vein thrombosis
|
0.11%
6/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.28%
15/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Diabetic vascular disorder
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Dry gangrene
|
0.11%
6/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Femoral artery aneurysm
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Hypertension
|
0.15%
8/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.25%
13/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Hypertensive crisis
|
0.13%
7/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.25%
13/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Hypertensive emergency
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Hypertensive urgency
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Hypotension
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.13%
7/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Hypovolaemic shock
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Intermittent claudication
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Internal haemorrhage
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Leriche syndrome
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Lymphoedema
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Orthostatic hypotension
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.30%
16/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.28%
15/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Peripheral artery stenosis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Peripheral embolism
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Peripheral ischaemia
|
0.15%
8/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.09%
5/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Peripheral vascular disorder
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Subclavian steal syndrome
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Varicose ulceration
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Varicose vein
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Vascular disorders
Vasculitis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Surgical and medical procedures
Aortic aneurysm repair
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Surgical and medical procedures
Foot amputation
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Surgical and medical procedures
Hysterectomy
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Surgical and medical procedures
Intraocular lens implant
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Surgical and medical procedures
Mitral valve replacement
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Surgical and medical procedures
Nephrectomy
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign laryngeal neoplasm
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of urethra
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign renal neoplasm
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma recurrent
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage 0
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.09%
5/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage III
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma stage IV
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chloroma
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.11%
6/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage 0
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ear neoplasm
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
External ear neoplasm malignant
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.19%
10/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.44%
23/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage III
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic uterine cancer
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal neoplasm benign
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour of the lung metastatic
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer stage II
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.09%
5/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary serous endometrial carcinoma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.19%
10/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.25%
13/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage IV
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer stage IV
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain oedema
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Asthenia
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Cardiac death
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Chest pain
|
0.13%
7/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Chronic fatigue syndrome
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Death
|
0.17%
9/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.23%
12/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Fatigue
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Gait disturbance
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Generalised oedema
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Influenza like illness
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Medical device site discharge
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Medical device site haematoma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Necrobiosis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Non-cardiac chest pain
|
0.19%
10/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.23%
12/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Oedema peripheral
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Peripheral swelling
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Pyrexia
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Soft tissue inflammation
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Sudden cardiac death
|
0.26%
14/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.15%
8/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Sudden death
|
0.13%
7/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.09%
5/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Systemic inflammatory response syndrome
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
General disorders
Vascular stent stenosis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Psychiatric disorders
Acute stress disorder
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Psychiatric disorders
Bipolar disorder
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Psychiatric disorders
Confusional state
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Psychiatric disorders
Conversion disorder
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Psychiatric disorders
Depression
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Psychiatric disorders
Hallucination
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Reproductive system and breast disorders
Adnexa uteri cyst
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.13%
7/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Reproductive system and breast disorders
Prostatitis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Reproductive system and breast disorders
Vulval disorder
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Airway burns
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer haemorrhage
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.13%
7/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.13%
7/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Colon injury
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Dural tear
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Fall
|
0.42%
22/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.25%
13/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.13%
7/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.13%
7/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.23%
12/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.28%
15/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.13%
7/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.13%
7/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.09%
5/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.26%
14/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.30%
16/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Incarcerated parastomal hernia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Limb fracture
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Periprocedural myocardial infarction
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Procedural shock
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.13%
7/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.15%
8/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.25%
13/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.17%
9/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.09%
5/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Scratch
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Stomal hernia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haematoma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.11%
6/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Wound
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.13%
7/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.09%
5/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
Alanine aminotransferase increased
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
Blood glucose decreased
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
Blood glucose increased
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.09%
5/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
Blood pressure increased
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
C-reactive protein increased
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
Catheterisation cardiac
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
ECG signs of myocardial ischaemia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
Electrocardiogram PR prolongation
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
Enterococcus test positive
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
Glomerular filtration rate decreased
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
Haemoglobin decreased
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
International normalised ratio increased
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
Klebsiella test positive
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
Liver function test increased
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
Transaminases increased
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
Troponin increased
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Investigations
Blood creatinine increased
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Acute coronary syndrome
|
0.13%
7/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.15%
8/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Acute left ventricular failure
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.11%
6/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.91%
48/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
1.1%
59/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Acute right ventricular failure
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Angina pectoris
|
0.34%
18/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.47%
25/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Angina unstable
|
0.83%
44/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.98%
52/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Aortic valve sclerosis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Aortic valve stenosis
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Arrhythmia
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Atrial fibrillation
|
0.64%
34/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.66%
35/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Atrial flutter
|
0.11%
6/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.23%
12/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Atrioventricular block complete
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.26%
14/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Bifascicular block
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Bradycardia
|
0.13%
7/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.13%
7/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Bundle branch block
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Cardiac aneurysm
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Cardiac arrest
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.21%
11/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Cardiac disorder
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Cardiac failure
|
1.8%
94/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
2.8%
147/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Cardiac failure acute
|
0.34%
18/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.53%
28/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Cardiac failure chronic
|
0.17%
9/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.51%
27/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.43%
23/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.87%
46/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.11%
6/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.13%
7/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Cardiogenic shock
|
0.11%
6/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.09%
5/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Cardiohepatic syndrome
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Coronary artery disease
|
0.28%
15/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.42%
22/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Coronary artery occlusion
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Coronary artery perforation
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Coronary artery stenosis
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Heart valve incompetence
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Hypertensive heart disease
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Left ventricular failure
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.09%
5/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Mitral valve incompetence
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Myocardial infarction
|
0.45%
24/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
1.0%
55/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.11%
6/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.13%
7/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Nodal arrhythmia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Palpitations
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Pericarditis
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Prosthetic cardiac valve thrombosis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Pulseless electrical activity
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Right ventricular failure
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Sinus bradycardia
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Sinus node dysfunction
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.11%
6/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Subendocardial ischaemia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Tachycardia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Ventricular fibrillation
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Ventricular flutter
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Cardiac disorders
Ventricular tachycardia
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Blood and lymphatic system disorders
Abdominal lymphadenopathy
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.11%
6/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Blood and lymphatic system disorders
Antiphospholipid syndrome
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.11%
6/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Blood and lymphatic system disorders
Hypoprothrombinaemia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.11%
6/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.17%
9/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.21%
11/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.23%
12/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.17%
9/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.36%
19/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory disease
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.17%
9/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.19%
10/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Nocturnal dyspnoea
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Pickwickian syndrome
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.13%
7/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.25%
13/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.15%
8/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.15%
8/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.15%
8/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Amnesia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Ataxia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Auditory nerve disorder
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Autonomic neuropathy
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Brain injury
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Brain stem ischaemia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Carotid artery stenosis
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Cauda equina syndrome
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Cerebellar stroke
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Cerebral infarction
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.11%
6/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.25%
13/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.30%
16/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Dementia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Depressed level of consciousness
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Diabetic encephalopathy
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Diabetic hyperosmolar coma
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Diabetic neuropathy
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Dizziness
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Facial paralysis
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.15%
8/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Headache
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Hemiparesis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Hemiplegia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Ischaemic stroke
|
0.55%
29/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.68%
36/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Lacunar infarction
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Lacunar stroke
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Loss of consciousness
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Migraine
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Nerve compression
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Post stroke seizure
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Presyncope
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Radiculopathy
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Sacral radiculopathy
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Sciatica
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Seizure
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Somnolence
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Status epilepticus
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Syncope
|
0.49%
26/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.51%
27/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Tension headache
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Toxic encephalopathy
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.11%
6/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.26%
14/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Vascular encephalopathy
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Nervous system disorders
Vertebrobasilar stroke
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Eye disorders
Amaurosis fugax
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Eye disorders
Angle closure glaucoma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Eye disorders
Cataract
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.09%
5/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Eye disorders
Corneal degeneration
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Eye disorders
Dermatochalasis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Eye disorders
Diabetic retinopathy
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Eye disorders
Diplopia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Eye disorders
Eyelid cyst
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Eye disorders
Glaucoma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Eye disorders
Macular fibrosis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Eye disorders
Papilloedema
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Eye disorders
Retinal artery occlusion
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Eye disorders
Retinal detachment
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Eye disorders
Retinal haemorrhage
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Eye disorders
Retinal ischaemia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Eye disorders
Visual impairment
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Eye disorders
Vitreous haemorrhage
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Ear and labyrinth disorders
Vertigo
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.11%
6/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.11%
6/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Colitis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Constipation
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.09%
5/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Duodenitis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Enteritis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Faecaloma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Gastric polyps
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Gastritis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.09%
5/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Gastrointestinal polyp haemorrhage
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Gastrooesophageal sphincter insufficiency
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Ileus
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Melaena
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Mesenteric arterial occlusion
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Oesophageal stent stenosis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.23%
12/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Pancreatitis haemorrhagic
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Portal hypertensive gastropathy
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Proctitis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Strangulated umbilical hernia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Gastrointestinal disorders
Vomiting
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.11%
6/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
61/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.98%
52/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Calculus bladder
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Calculus urinary
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.26%
14/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.34%
18/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Cystitis glandularis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Diabetic end stage renal disease
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Eosinophilic cystitis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Haematuria
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Hypertensive nephropathy
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.15%
8/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.09%
5/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Obstructive nephropathy
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Renal colic
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Renal disorder
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Renal failure
|
0.21%
11/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.30%
16/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Renal haematoma
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Renal hypertension
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Renal impairment
|
0.23%
12/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.26%
14/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Stag horn calculus
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Renal and urinary disorders
Urinary retention
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Biliary colic
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Cholangitis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.09%
5/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.19%
10/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.19%
10/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Cholestasis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Gallbladder rupture
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Hepatobiliary disorders
Pneumobilia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Product Issues
Device breakage
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Product Issues
Device dislocation
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Product Issues
Device failure
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Product Issues
Device loosening
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Product Issues
Device malfunction
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Product Issues
Device occlusion
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Cutaneous loxoscelism
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.26%
14/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.17%
9/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Ischaemic skin ulcer
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Necrobiosis lipoidica diabeticorum
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Neuropathic ulcer
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Oedema blister
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.23%
12/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Crowned dens syndrome
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Gouty tophus
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.13%
7/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.17%
9/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.23%
12/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Endocrine disorders
Empty sella syndrome
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.11%
6/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.13%
7/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.17%
9/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.32%
17/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.47%
25/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.21%
11/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.11%
6/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Gout
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.26%
14/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.21%
11/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.66%
35/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.59%
31/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.17%
9/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Increased insulin requirement
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.26%
14/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Metabolic syndrome
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Obesity
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.06%
3/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Abdominal abscess
|
0.04%
2/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Abdominal wall abscess
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Abscess limb
|
0.09%
5/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.09%
5/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Abscess neck
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Acarodermatitis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Acute endocarditis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Anal abscess
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.04%
2/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Appendicitis
|
0.08%
4/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Arthritis bacterial
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.08%
4/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Atypical pneumonia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Bacteraemia
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.06%
3/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Bacterial colitis
|
0.00%
0/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.02%
1/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Infections and infestations
Bacterial parotitis
|
0.02%
1/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
0.00%
0/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
Other adverse events
| Measure |
Sotagliflozin
n=5291 participants at risk
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.
|
Placebo
n=5286 participants at risk
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
373/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
4.8%
253/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
7.2%
380/5291 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
7.5%
395/5286 • First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months)
Number of Deaths (All causes) is based on all randomized participants (n=5292, 5292). Adverse Events are based on the Safety population that included all randomized participants who received at least 1 dose of investigational medicinal product (n=5291, 5286).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution must provide any proposed publication or presentation to Sponsor for Sponsor's review, comment and approval at least thirty (30) days prior to the proposed submission for publication date or the proposed presentation date. Sponsor shall have the right to have deleted from the final version of the publication any confidential information, proprietary information, or patentable subject matter.
- Publication restrictions are in place
Restriction type: OTHER