Trial Outcomes & Findings for EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin) (NCT NCT03594110)
NCT ID: NCT03594110
Last Updated: 2025-07-20
Results Overview
Time to first occurrence of kidney disease progression (KDP) or cardiovascular death is reported as incidence rate of first occurrence of KDP or adjudicated cardiovascular death. Incidence rate= (Number of patients who experienced the event of first occurrence of KDP or cardiovascular death)\*100/(patient years at risk (pt-yrs at risk). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. Kidney disease progression was defined as: * end stage kidney disease (defined as the initiation of maintenance dialysis or receipt of a kidney transplant) OR * a sustained decline in estimated glomerular filtration rate (eGFR) to \<10 mL/min/1.73m\^2 OR * renal death OR * a sustained decline of ≥40% in eGFR from randomisation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
6609 participants
Primary outcome timeframe
From the day of randomisation to the day of the final follow-up visit in the interventional part of the trial, up to 1136 days.
Results posted on
2025-07-20
Participant Flow
Trial with a interventional and a non-interventional part (post-trial follow-up). Interventional part: event-driven (ca. 1070 primary outcome events). Alongside the trial, a fraction of patients randomized in the interventional part gave consent to two sub-studies: body composition measurement and magnetic resonance imaging. Non-interventional part: patients who gave consent were observed for ca. 2 years.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Placebo
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
|
Empagliflozin 10 mg
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
|
|---|---|---|
|
Interventional Part
STARTED
|
3305
|
3304
|
|
Interventional Part
Treated
|
3305
|
3304
|
|
Interventional Part
Body Composition Measurement (BCM) Sub-study
|
328
|
332
|
|
Interventional Part
Magnetic Resonance Imaging (MRI) Sub-study
|
79
|
93
|
|
Interventional Part
COMPLETED
|
2457
|
2549
|
|
Interventional Part
NOT COMPLETED
|
848
|
755
|
|
Non-interventional Part
STARTED
|
2419
|
2472
|
|
Non-interventional Part
COMPLETED
|
2371
|
2427
|
|
Non-interventional Part
NOT COMPLETED
|
48
|
45
|
Reasons for withdrawal
| Measure |
Placebo
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
|
Empagliflozin 10 mg
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
|
|---|---|---|
|
Interventional Part
Participant concerned about study treatment
|
23
|
28
|
|
Interventional Part
Doctor advice
|
38
|
40
|
|
Interventional Part
Participants' wish
|
89
|
68
|
|
Interventional Part
Adverse event-non-fatal events
|
119
|
116
|
|
Interventional Part
Study drug stopped, reason missing
|
336
|
294
|
|
Interventional Part
Cannot attend clinic because of personal problems
|
8
|
16
|
|
Interventional Part
Cannot attend clinic because moving out of the area
|
15
|
9
|
|
Interventional Part
Contraindicated drug started
|
32
|
18
|
|
Interventional Part
Other reasons (include any category with a frequency <20 patients in total)
|
58
|
45
|
|
Interventional Part
Adverse event-Serious fatal events
|
130
|
121
|
|
Non-interventional Part
Withdrawal by Subject
|
3
|
4
|
|
Non-interventional Part
Lost to Follow-up
|
45
|
41
|
Baseline Characteristics
EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)
Baseline characteristics by cohort
| Measure |
Placebo
n=3305 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
|
Empagliflozin 10 mg
n=3304 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
|
Total
n=6609 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
White
|
1920 Participants
n=99 Participants
|
1939 Participants
n=107 Participants
|
3859 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/ African-American
|
134 Participants
n=99 Participants
|
128 Participants
n=107 Participants
|
262 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1199 Participants
n=99 Participants
|
1194 Participants
n=107 Participants
|
2393 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other including mixed race
|
52 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Age, Continuous
|
63.3 Years
STANDARD_DEVIATION 13.9 • n=99 Participants
|
63.4 Years
STANDARD_DEVIATION 13.9 • n=107 Participants
|
63.3 Years
STANDARD_DEVIATION 13.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1095 Participants
n=99 Participants
|
1097 Participants
n=107 Participants
|
2192 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2210 Participants
n=99 Participants
|
2207 Participants
n=107 Participants
|
4417 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
119 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
222 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
723 Participants
n=99 Participants
|
708 Participants
n=107 Participants
|
1431 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2463 Participants
n=99 Participants
|
2493 Participants
n=107 Participants
|
4956 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From the day of randomisation to the day of the final follow-up visit in the interventional part of the trial, up to 1136 days.Population: Randomised set (RS) included all randomised participants, whether treated or not.
Time to first occurrence of kidney disease progression (KDP) or cardiovascular death is reported as incidence rate of first occurrence of KDP or adjudicated cardiovascular death. Incidence rate= (Number of patients who experienced the event of first occurrence of KDP or cardiovascular death)\*100/(patient years at risk (pt-yrs at risk). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. Kidney disease progression was defined as: * end stage kidney disease (defined as the initiation of maintenance dialysis or receipt of a kidney transplant) OR * a sustained decline in estimated glomerular filtration rate (eGFR) to \<10 mL/min/1.73m\^2 OR * renal death OR * a sustained decline of ≥40% in eGFR from randomisation.
Outcome measures
| Measure |
Placebo
n=3305 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
|
Empagliflozin 10 mg
n=3304 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
|
|---|---|---|
|
Interventional Part: Time to First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated')
|
8.96 patients with events/100 pt-yrs at risk
Interval 8.23 to 9.72
|
6.85 patients with events/100 pt-yrs at risk
Interval 6.22 to 7.51
|
PRIMARY outcome
Timeframe: From the day of randomization in the interventional part of the trial until the individual day of end of study in the non-interventional part of the trial. Up to 1869 days.Population: Randomised set (RS): included all randomised participants, whether treated or not.
Time to first occurrence of kidney disease progression (KDP) or cardiovascular death is reported as incidence of progression of kidney disease or death from cardiovascular causes in the interventional part of the trial and in the post-trial follow-up (non-interventional part). Incidence rate= (Number of patients who experienced the event of first occurrence of KDP or cardiovascular death)\*100/(patient years at risk (pt-yrs at risk). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. Kidney disease progression was defined as: * a sustained decline in eGFR to less than 10 mL/min/1.73m\^2 OR * renal death OR * sustained decline of more than 40% in eGFR from randomization.
Outcome measures
| Measure |
Placebo
n=3305 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
|
Empagliflozin 10 mg
n=3304 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
|
|---|---|---|
|
Overall Study: Time to the First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated')
|
9.99 patients with events/100 pt-yrs at risk
Interval 9.38 to 10.62
|
8.36 patients with events/100 pt-yrs at risk
Interval 7.81 to 8.93
|
SECONDARY outcome
Timeframe: From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1140 days.Population: Randomised set (RS) included all randomised participants, whether treated or not.
Time to first hospitalization for heart failure ('as adjudicated') or cardiovascular death ('as adjudicated') is reported as incidence rate of first hospitalization for heart failure or cardiovascular death. Incidence rate= (Number of patients who experienced the event of first hospitalization for heart failure or cardiovascular death) \*100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Outcome measures
| Measure |
Placebo
n=3305 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
|
Empagliflozin 10 mg
n=3304 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
|
|---|---|---|
|
Key Secondary Endpoint: Interventional Part - Time to First Hospitalization for Heart Failure ('as Adjudicated') or Cardiovascular Death ('as Adjudicated')
|
2.39 patients with events/100 pt-yrs at risk
Interval 2.03 to 2.78
|
2.04 patients with events/100 pt-yrs at risk
Interval 1.7 to 2.4
|
SECONDARY outcome
Timeframe: From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1140 days.Population: Randomised set (RS) included all randomised participants, whether treated or not.
Time to occurrences of all-cause hospitalizations is reported as total number of all-cause hospitalizations (first and recurrent combined).
Outcome measures
| Measure |
Placebo
n=3305 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
|
Empagliflozin 10 mg
n=3304 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
|
|---|---|---|
|
Key Secondary Endpoint: Interventional Part - Time to Occurrences of All-cause Hospitalizations (First and Recurrent Combined)
|
1895 events (first and recurrent)
|
1612 events (first and recurrent)
|
SECONDARY outcome
Timeframe: From the day of randomisation to the day of the final follow-up visit in the interventional part of the trial, up to 1140 days.Population: Randomised set (RS) included all randomised participants, whether treated or not.
Time to death from any cause is reported as incidence rate of death from any cause. Incidence rate of death from any cause = (Number of patients who experienced the event of death from any cause) \* 100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Outcome measures
| Measure |
Placebo
n=3305 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
|
Empagliflozin 10 mg
n=3304 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
|
|---|---|---|
|
Key Secondary Endpoint: Interventional Part - Time to Death From Any Cause ('as Adjudicated')
|
2.59 patients with events/100 pt-yrs at risk
Interval 2.21 to 3.0
|
2.29 patients with events/100 pt-yrs at risk
Interval 1.94 to 2.68
|
SECONDARY outcome
Timeframe: From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1136 days.Population: Randomised set (RS) included all randomised participants, whether treated or not.
Time to first occurrence of kidney disease progression (KDP) is reported as incidence rate of first occurrence of kidney disease progression. Incidence rate of first occurrence of kidney disease progression= (Number of patients who experienced the event of first occurrence of kidney disease progression) \*100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. Kidney disease progression was defined as: * end stage kidney disease (defined as the initiation of maintenance dialysis or receipt of a kidney transplant) OR * a sustained decline in estimated glomerular filtration rate (eGFR) to \<10 mL/min/1.73m\^2 OR * renal death OR * a sustained decline of ≥40% in eGFR from randomisation).
Outcome measures
| Measure |
Placebo
n=3305 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
|
Empagliflozin 10 mg
n=3304 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
|
|---|---|---|
|
Interventional Part: Time to First Occurrence of Kidney Disease Progression
|
8.09 patients with events/100 pt-yrs at risk
Interval 7.4 to 8.81
|
6.09 patients with events/100 pt-yrs at risk
Interval 5.5 to 6.72
|
SECONDARY outcome
Timeframe: From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1140 days.Population: Randomised set (RS) included all randomised participants, whether treated or not.
Time to cardiovascular death ('as adjudicated') is reported as incidence rate of cardiovascular death. Incidence rate of cardiovascular death= (Number of patients who experienced the event of cardiovascular death) \*100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Outcome measures
| Measure |
Placebo
n=3305 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
|
Empagliflozin 10 mg
n=3304 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
|
|---|---|---|
|
Interventional Part: Time to Cardiovascular Death ('as Adjudicated')
|
1.08 patients with events/100 pt-yrs at risk
Interval 0.84 to 1.35
|
0.91 patients with events/100 pt-yrs at risk
Interval 0.69 to 1.15
|
SECONDARY outcome
Timeframe: From the day of randomization to the day of the final follow-up visit in the interventional part of the trial, up to 1140 days.Population: Randomised set (RS) included all randomised participants, whether treated or not.
Time to first occurrence of cardiovascular death ('as adjudicated') or end stage kidney disease is reported as incidence rate of first occurrence of cardiovascular death or end stage kidney disease (ESKD). Incidence rate of first occurrence cardiovascular death or end stage kidney disease (ESKD)= (Number of patients who experienced the event of first occurrence of cardiovascular death or end stage kidney disease (ESKD)) \*100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. ESKD was defined as the initiation of maintenance dialysis or receipt of a kidney transplant.
Outcome measures
| Measure |
Placebo
n=3305 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
|
Empagliflozin 10 mg
n=3304 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
|
|---|---|---|
|
Interventional Part: Time to First Occurrence Cardiovascular Death ('as Adjudicated') or End Stage Kidney Disease (ESKD)
|
3.45 patients with events/100 pt-yrs at risk
Interval 3.01 to 3.92
|
2.55 patients with events/100 pt-yrs at risk
Interval 2.18 to 2.96
|
SECONDARY outcome
Timeframe: From the day of randomization in the interventional part of the trial until the individual day of end of study in the non-interventional part of the trial. Up to 1869 days.Population: Randomised set (RS) included all randomised participants, whether treated or not.
The time to first occurrence of kidney disease progression in the interventional part of the trial and in the post-trial follow-up (non-interventional part) is reported as the incidence rate of first occurrence of kidney disease progression. Incidence rate of first occurrence of kidney disease progression= (Number of patients who experienced the event of first occurrence of kidney disease progression) \*100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. Kidney disease progression was defined as: * end stage kidney disease (defined as the initiation of maintenance dialysis or receipt of a kidney transplant) OR * a sustained decline in estimated glomerular filtration rate (eGFR) to \<10 mL/min/1.73m\^2 OR * renal death OR * a sustained decline of ≥40% in eGFR from randomisation.
Outcome measures
| Measure |
Placebo
n=3305 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
|
Empagliflozin 10 mg
n=3304 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
|
|---|---|---|
|
Overall Study: Time to First Occurrence of Kidney Disease Progression
|
8.95 patients with events/100 pt-yrs at risk
Interval 8.37 to 9.55
|
7.52 patients with events/100 pt-yrs at risk
Interval 7.0 to 8.06
|
SECONDARY outcome
Timeframe: From the day of randomization in the interventional part of the trial until the individual day of end of study in the non-interventional part of the trial. Up to 1869 days.Population: Randomised set (RS) included all randomised participants, whether treated or not.
Time to first occurrence of death from any cause or end stage kidney disease (ESKD) in the interventional part of the trial and in the post-trial follow-up (non-interventional part) is reported as incidence rate of first occurrence of death from any cause or ESKD. Incidence rate of first occurrence of death from any cause or end stage kidney disease (ESKD)= (Number of patients who experienced the event of first occurrence of death any cause or end stage kidney disease (ESKD)) \*100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. ESKD was defined as the initiation of maintenance dialysis or receipt of a kidney transplant.
Outcome measures
| Measure |
Placebo
n=3305 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
|
Empagliflozin 10 mg
n=3304 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
|
|---|---|---|
|
Overall Study: Time to First Occurrence of Death From Any Cause or ESKD
|
6.08 patients with events/100 pt-yrs at risk
Interval 5.62 to 6.55
|
5.13 patients with events/100 pt-yrs at risk
Interval 4.71 to 5.56
|
SECONDARY outcome
Timeframe: From the day of randomization in the interventional part of the trial until the individual day of end of study in the non-interventional part of the trial. Up to 1869 days.Population: Randomised set (RS) included all randomised participants, whether treated or not.
Time to first occurrence of end stage kidney disease (ESKD) in the interventional part of the trial and in the post-trial follow-up (non-interventional part) is reported as incidence rate of first occurrence of ESKD. Incidence rate of first occurrence of end stage kidney disease (ESKD)= (Number of patients who experienced the event of first occurrence of ESKD) \*100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. ESKD was defined as the initiation of maintenance dialysis or receipt of a kidney transplant.
Outcome measures
| Measure |
Placebo
n=3305 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
|
Empagliflozin 10 mg
n=3304 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
|
|---|---|---|
|
Overall Study: Time to First Occurrence of ESKD
|
3.49 patients with events/100 pt-yrs at risk
Interval 3.14 to 3.85
|
2.72 patients with events/100 pt-yrs at risk
Interval 2.41 to 3.03
|
SECONDARY outcome
Timeframe: MMRM included measurements at baseline, 2 months, and 18 months.Population: Body composition measurement sub-study: all randomized patients who signed the informed consent form to participate in the body composition measurement sub-study, whether treated or not, with at least one valid BCM measurement. Patients with non-valid follow-up measurements were excluded from the analysis.
Mean absolute fluid overload averaged over time in the body composition measurement sub-study. Fluid overload or overhydration was measured using bioimpedance spectroscopy which derives the amount of water in liters (L) in the adipose tissue and lean mass tissues and computed as the difference between expected (based upon weight and body composition) versus measured extracellular water volume, with positive values representing excess fluid. A mixed model of repeated measures (MMRM) with terms for baseline, age, sex, screening diabetes status, local screening eGFR, local screening UACR, treatment, treatment-by-time interaction and baseline-by-time interaction was used for the analysis. The weighted mean of the values at 2 and 18 months.
Outcome measures
| Measure |
Placebo
n=309 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
|
Empagliflozin 10 mg
n=311 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
|
|---|---|---|
|
Body Composition Measurement Sub-study: Mean Absolute Fluid Overload, Averaged Over Time
|
0.34 Liters
Standard Error 0.05
|
0.10 Liters
Standard Error 0.05
|
SECONDARY outcome
Timeframe: At 18 months.Population: Magnetic resonance imaging sub-study: all randomized patients who signed the informed consent form to participate in magnetic resonance imaging sub-study, whether treated or not.
Kidney cortical T1 mapping using the modified Look-Locker inversion recovery (MOLLI) measured by magnetic resonance imaging (MRI) in the placebo and empagliflozin groups. A linear regression with terms for age, sex, screening diabetes status, local screening eGFR, local screening UACR was used in the analysis.
Outcome measures
| Measure |
Placebo
n=79 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
|
Empagliflozin 10 mg
n=93 Participants
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
|
|---|---|---|
|
Magnetic Resonance Imaging Sub-study: Kidney Cortical T1 Mapping as Measured by Modified Look-Locker Inversion Recovery (MOLLI) at 18 Months
|
1634 milliseconds
Standard Error 11
|
1622 milliseconds
Standard Error 10
|
Adverse Events
Placebo
Serious events: 1167 serious events
Other events: 262 other events
Deaths: 353 deaths
Empagliflozin 10 mg
Serious events: 1089 serious events
Other events: 228 other events
Deaths: 314 deaths
Serious adverse events
| Measure |
Placebo
n=3305 participants at risk
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
|
Empagliflozin 10 mg
n=3304 participants at risk
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
|
|---|---|---|
|
Infections and infestations
Postoperative wound infection
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.30%
10/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Blood and lymphatic system disorders
Aplasia pure red cell
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.15%
5/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.18%
6/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Angina pectoris
|
0.57%
19/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.24%
8/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Angina unstable
|
0.27%
9/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.33%
11/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Aortic valve disease
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.21%
7/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Arrhythmia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Atrial fibrillation
|
0.97%
32/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.54%
18/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Atrial flutter
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Atrioventricular block
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Bradycardia
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.15%
5/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Bundle branch block
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Cardiac arrest
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Cardiac failure
|
1.3%
44/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
1.2%
41/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Cardiac fibrillation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Cardiac sarcoidosis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Coronary artery disease
|
0.42%
14/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.21%
7/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Coronary vein stenosis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.30%
10/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.15%
5/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
1.4%
45/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
1.00%
33/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Malignant hypertensive heart disease
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Myocardial infarction
|
0.94%
31/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
1.2%
39/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Palpitations
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Pericardial effusion
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Pericarditis
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Sinus arrest
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Sinus bradycardia
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Tachycardia
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Trifascicular block
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Congenital, familial and genetic disorders
Adenomatous polyposis coli
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Congenital, familial and genetic disorders
Congenital vesicoureteric reflux
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Congenital, familial and genetic disorders
Heart block congenital
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Congenital, familial and genetic disorders
Myocardial bridging
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Congenital, familial and genetic disorders
Osteoporosis-pseudoglioma syndrome
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Congenital, familial and genetic disorders
Thalassaemia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Ear and labyrinth disorders
Vertigo
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Endocrine disorders
Hyperthyroidism
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Endocrine disorders
Hypothyroidism
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Eye disorders
Amaurosis fugax
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Eye disorders
Cataract
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Eye disorders
Diabetic eye disease
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Eye disorders
Glaucoma
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Eye disorders
Lacrimal disorder
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Eye disorders
Lens dislocation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Eye disorders
Macular degeneration
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Eye disorders
Retinal artery occlusion
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Eye disorders
Retinal detachment
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Eye disorders
Retinal haemorrhage
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Eye disorders
Retinal tear
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Eye disorders
Retinopathy proliferative
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Eye disorders
Ulcerative keratitis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Eye disorders
Vitreous haemorrhage
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.21%
7/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Anal fissure
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Ascites
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Chronic gastrointestinal bleeding
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Colitis
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Constipation
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Gastritis
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.18%
6/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Gastrointestinal ischaemia
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Haematemesis
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Ileus
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.21%
7/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.15%
5/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Melaena
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Mesenteric artery stenosis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Nausea
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.15%
5/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Retroperitoneal fibrosis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.30%
10/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Gastrointestinal disorders
Vomiting
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
General disorders
Autoresuscitation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
General disorders
Chest discomfort
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
General disorders
Chest pain
|
0.36%
12/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.21%
7/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
General disorders
Death
|
0.30%
10/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.30%
10/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
General disorders
Gait disturbance
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
General disorders
General physical health deterioration
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
General disorders
Incarcerated hernia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
General disorders
Necrosis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
General disorders
Non-cardiac chest pain
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
General disorders
Oedema
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
General disorders
Pain
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
General disorders
Sudden cardiac death
|
0.51%
17/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.36%
12/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
General disorders
Sudden death
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
General disorders
Vascular stent occlusion
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
General disorders
Vascular stent thrombosis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Hepatobiliary disorders
Cholangitis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.18%
6/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.27%
9/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.18%
6/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Hepatobiliary disorders
Gallbladder necrosis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Hepatobiliary disorders
Hepatitis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Hepatobiliary disorders
Jaundice
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Hepatobiliary disorders
Liver injury
|
0.21%
7/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.15%
5/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Hepatobiliary disorders
Non-alcoholic fatty liver
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Immune system disorders
Allergy to vaccine
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Abdominal abscess
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Abdominal sepsis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Abscess
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Abscess soft tissue
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Appendicitis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.15%
5/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Arthritis infective
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Bacterial infection
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Bone abscess
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Bronchitis
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Cardiac valve abscess
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Cellulitis
|
0.36%
12/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.27%
9/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Cellulitis gangrenous
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Clostridium colitis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Corona virus infection
|
3.2%
107/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
3.0%
98/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Cystitis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Device related infection
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Diabetic foot infection
|
0.18%
6/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.51%
17/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Diabetic gangrene
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Diarrhoea infectious
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Diverticulitis
|
0.18%
6/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.21%
7/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Ear infection
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Empyema
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Endocarditis
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Endocarditis bacterial
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Enterobacter sepsis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Escherichia sepsis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Gallbladder empyema
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Gangrene
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Gastroenteritis
|
0.30%
10/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.24%
8/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Gastrointestinal infection
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Herpes zoster
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Influenza
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Inguinal hernia gangrenous
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Joint abscess
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Labyrinthitis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Laryngitis bacterial
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Localised infection
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Meningoencephalitis bacterial
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Muscle abscess
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Nail infection
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Necrotising soft tissue infection
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Neutropenic sepsis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Oral infection
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Orchitis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Osteomyelitis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Osteomyelitis bacterial
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Otitis externa
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Pancreatic abscess
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Perineal abscess
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Periodontitis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Perirectal abscess
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Peritonitis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Peritonitis bacterial
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Pleural infection
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Pneumonia
|
1.3%
42/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
1.2%
39/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Pneumonia bacterial
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.21%
7/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Prostate infection
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Pseudomonas infection
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Pyelocystitis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Pyelonephritis
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Pyelonephritis acute
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Renal abscess
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Respiratory tract infection
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Retroperitoneal abscess
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Sepsis
|
0.18%
6/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.24%
8/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Septic shock
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Severe invasive streptococcal infection
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Skin bacterial infection
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Skin infection
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Spinal cord abscess
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Staphylococcal infection
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Subcutaneous abscess
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Systemic bacterial infection
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Thrombophlebitis septic
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Urinary tract infection
|
0.94%
31/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.82%
27/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.18%
6/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.21%
7/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Urosepsis
|
0.15%
5/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.18%
6/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Viral diarrhoea
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Viral infection
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Viral pericarditis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Viral pharyngitis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Wound abscess
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Wound infection
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Wound infection bacterial
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.18%
6/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Crush injury
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Fall
|
0.57%
19/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.51%
17/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.15%
5/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.27%
9/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.15%
5/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Foreign body aspiration
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Fractured ischium
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.15%
5/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.21%
7/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.15%
5/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Inadequate haemodialysis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Oesophageal injury
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Post angioplasty restenosis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.15%
5/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Spinal cord injury lumbar
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Alanine aminotransferase increased
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Angiogram
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Angiogram peripheral
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Arteriogram carotid
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Arteriogram coronary
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Biopsy intestine
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Biopsy kidney
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.18%
6/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Biopsy liver
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Biopsy prostate
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Blood creatinine increased
|
1.7%
56/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
1.3%
43/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Blood glucose increased
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Blood potassium decreased
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Blood potassium increased
|
2.6%
87/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
2.3%
76/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Blood pressure decreased
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Blood pressure increased
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Blood sodium decreased
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Bronchoscopy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Catheterisation cardiac
|
0.33%
11/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.24%
8/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Colonoscopy
|
0.27%
9/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Computerised tomogram
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Coronavirus test positive
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.18%
6/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Cystoscopy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Endoscopy gastrointestinal
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Endoscopy upper gastrointestinal tract
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Heart rate irregular
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Investigation
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Laryngoscopy
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Nuclear magnetic resonance imaging abdominal
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Sleep study
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Ultrasound kidney
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Ultrasound liver
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Ultrasound scan
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Investigations
Ureteroscopy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.61%
20/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.67%
22/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.70%
23/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.58%
19/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.18%
6/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.15%
5/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.15%
5/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.27%
9/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Gout
|
0.15%
5/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.15%
5/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.42%
14/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.24%
8/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.42%
14/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.42%
14/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.33%
11/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.36%
12/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.15%
5/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Insulin-requiring type 2 diabetes mellitus
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Ketosis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Bone debridement
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.18%
6/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.27%
9/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.24%
8/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Metabolism and nutrition disorders
Uraemic acidosis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.15%
5/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Joint destruction
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.30%
10/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenosquamous cell lung cancer
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenosquamous cell lung cancer stage IV
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic astrocytoma
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiosarcoma
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.18%
6/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.33%
11/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastrointestinal neoplasm
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biliary neoplasm
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder adenocarcinoma stage III
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.18%
6/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Parathyroidectomy
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer male
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the prostate
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of penis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of skin
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell sarcoma of the kidney
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage 0
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage I
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage III
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage IV
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer stage III
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ear neoplasm malignant
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Enchondromatosis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (MALT type)
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicle centre lymphoma, follicular grade I, II, III
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer metastatic
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer recurrent
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrooesophageal cancer
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.18%
6/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer stage II
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.15%
5/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of renal pelvis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma recurrent
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spinal cord
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic bronchial carcinoma
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Monoclonal gammopathy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative neoplasm
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage I
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage II
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteosarcoma
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma stage II
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma stage IV
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal sarcoma
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma recurrent
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural neoplasm
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.30%
10/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.24%
8/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer recurrent
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer stage II
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.18%
6/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Soft tissue neoplasm
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma malignant
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transformation to acute myeloid leukaemia
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Basal ganglia infarction
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Basilar artery thrombosis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Cerebellar infarction
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Cerebral infarction
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Cranial nerve paralysis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Dementia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Dizziness
|
0.15%
5/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Encephalopathy
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.18%
6/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.30%
10/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Headache
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.18%
6/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Hemiplegia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Hypoglycaemic encephalopathy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Ischaemic stroke
|
1.0%
34/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.91%
30/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Lacunar infarction
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Loss of consciousness
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Microvascular cranial nerve palsy
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Migraine
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Movement disorder
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Pelvic floor repair
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Polyneuropathy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Post stroke seizure
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Presyncope
|
0.18%
6/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Seizure
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Spinal cord herniation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Status epilepticus
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Syncope
|
0.24%
8/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.48%
16/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.42%
14/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.36%
12/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Visual field defect
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Psychiatric disorders
Acute psychosis
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Psychiatric disorders
Anxiety
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Psychiatric disorders
Bipolar disorder
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Psychiatric disorders
Confusional state
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Psychiatric disorders
Delirium
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Psychiatric disorders
Mania
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Psychiatric disorders
Psychotic behaviour
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Psychiatric disorders
Psychotic disorder
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Psychiatric disorders
Suicide attempt
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.5%
117/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
2.8%
93/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Calculus urethral
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Calculus urinary
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Diabetic end stage renal disease
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.15%
5/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.27%
9/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
End stage renal disease
|
0.82%
27/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
1.1%
35/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Glomerulonephritis membranoproliferative
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.21%
7/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
IgA nephropathy
|
0.15%
5/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Lupus nephritis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Paraneoplastic nephrotic syndrome
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Renal colic
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Renal cyst
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Renal disorder
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Renal and urinary disorders
Urinary retention
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Reproductive system and breast disorders
Ovarian failure
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.15%
5/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Combined pulmonary fibrosis and emphysema
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.15%
5/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.18%
6/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.18%
6/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.15%
5/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.24%
8/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.15%
5/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Skin and subcutaneous tissue disorders
Diabetic neuropathic ulcer
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.18%
6/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Social circumstances
Social problem
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Aneurysm repair
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Angioplasty
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Ankle operation
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Aortic aneurysm repair
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Aortic valve repair
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Appendicectomy
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Arterial bypass operation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Arterial repair
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Arterial stent insertion
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
0.24%
8/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Arteriovenous shunt operation
|
0.36%
12/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.24%
8/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Bladder catheter removal
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Bladder catheterisation
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Bladder lesion excision
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Bladder operation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Bladder polypectomy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Bone operation
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
CSF shunt operation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Cardiac ablation
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.15%
5/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Cardiac operation
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Cardiac pacemaker battery replacement
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.36%
12/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.30%
10/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Cardiac pacemaker removal
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Cardiac resynchronisation therapy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Cardioversion
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Peripheral artery angioplasty
|
0.21%
7/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Carotid artery stent insertion
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Peripheral artery bypass
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Carotid endarterectomy
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Cataract operation
|
0.82%
27/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.36%
12/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Chemotherapy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Chest wall operation
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.21%
7/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.15%
5/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Colectomy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Colostomy
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Colostomy closure
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.15%
5/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.24%
8/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Cyst removal
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Dialysis device insertion
|
0.57%
19/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.33%
11/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Ear operation
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Elbow operation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Endarterectomy
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Endometrial ablation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
External fixation of fracture
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Eye operation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Eyelid operation
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Foot amputation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.15%
5/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Fracture treatment
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Gallbladder operation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Gastric operation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Gastric stapling
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Gastrointestinal surgery
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Glaucoma surgery
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Haemorrhoid operation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Heart valve replacement
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Hepatectomy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Hepatic embolisation
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Hernia repair
|
0.15%
5/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Hip surgery
|
0.18%
6/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.18%
6/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Hospitalisation
|
0.39%
13/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.30%
10/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Hysterectomy
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Implantable defibrillator replacement
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Intervertebral disc operation
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Intestinal polypectomy
|
0.18%
6/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.15%
5/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Intra-cerebral aneurysm operation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Joint surgery
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.27%
9/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Knee operation
|
0.30%
10/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.18%
6/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Large intestine operation
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Leg amputation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.21%
7/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Liver operation
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Low density lipoprotein apheresis
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Lung operation
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Mastectomy
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Meniscus operation
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Middle ear operation
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Mitral valve repair
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Nasal operation
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Nephrectomy
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Oesophageal operation
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Oophorectomy
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Open reduction of fracture
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Oral surgery
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Ovarian operation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Packed red blood cell transfusion
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Pain management
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Pancreatic operation
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Peripheral artery stent insertion
|
0.12%
4/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.15%
5/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Peripheral endarterectomy
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Peripheral revascularisation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Prostatic operation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Radical prostatectomy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Radiotherapy
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Rectal prolapse repair
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Removal of foreign body from joint
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Removal of internal fixation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Renal stone removal
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Retinal laser coagulation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Retinal operation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Shoulder operation
|
0.15%
5/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Skin graft
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Spinal cord operation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Spinal operation
|
0.15%
5/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Stem cell transplant
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Subdural haematoma evacuation
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Thoracic operation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Thrombectomy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Thyroid operation
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Thyroidectomy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Toe amputation
|
0.33%
11/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.48%
16/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Tongue operation
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Tooth extraction
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Tracheostomy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Transmyocardial revascularisation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Transurethral bladder resection
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Tricuspid valve repair
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Ureteral stent insertion
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Ureteral stent removal
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Ureteric calculus removal
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Ureteric operation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Uterine dilation and curettage
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Surgical and medical procedures
Uterine operation
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Aortic aneurysm
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Aortic dissection
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Aortic dissection rupture
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Aortic occlusion
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Arterial occlusive disease
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Arterial stenosis
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
CT hypotension complex
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Circulatory collapse
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Deep vein thrombosis
|
0.27%
9/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Haematoma
|
0.09%
3/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Hypertension
|
0.24%
8/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.09%
3/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Hypertensive crisis
|
0.24%
8/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.15%
5/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Hypertensive emergency
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.06%
2/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Hypovolaemic shock
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Malignant hypertension
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Necrosis ischaemic
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Orthostatic hypotension
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Peripheral ischaemia
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Temporal arteritis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Thrombosis
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Vasculitis
|
0.06%
2/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.12%
4/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Vascular disorders
Vein rupture
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.00%
0/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.03%
1/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.03%
1/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
0.00%
0/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
Other adverse events
| Measure |
Placebo
n=3305 participants at risk
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
|
Empagliflozin 10 mg
n=3304 participants at risk
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
|
|---|---|---|
|
Metabolism and nutrition disorders
Gout
|
7.9%
262/3305 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
6.9%
228/3304 • All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
All-cause Mortality: Randomized set (RS): all randomized patients, whether treated or not. Adverse events reporting: Treated Set (TS): all patients who were dispensed randomized study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER