Trial Outcomes & Findings for Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis (NCT NCT04523220)
NCT ID: NCT04523220
Last Updated: 2023-07-21
Results Overview
Cumulative incidence risk of the first Composite of MB and CRNMB (ISTH) at month 6 is reported in the table. Descriptive time to composite of MB and CRNMB Events is reported in statistical analysis. Descriptive time to composite of treatment emergent major and CRNMB events \[in alignment with International Society on Thrombosis and Haemostatsis (ISTH) guidelines\] analyses were performed. The cumulative incidence function for the event-of-interest together with the corresponding confidence interval were estimated for each treatment arm using Aalen-Johansen estimators. Cumulative incidence of events up to the day, inclusive.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
704 participants
Primary outcome timeframe
From the first dose of study intervention up till 30 days after last study intervention in the main treatment period, up to 6 months
Results posted on
2023-07-21
Participant Flow
Study was conducted at multiple centers in 19 countries/regions, between 28-Aug-2020 (first participant first visit) and 30-May-2022 (last participant last visit).
A total of 859 participants were screened; 155 participants were not randomized. Most common reason for not being randomized was screen failure (144 participants). 704 participants were randomized to treatment; 18 participants did not receive treatment. The remaining 686 participants were treated.
Participant milestones
| Measure |
Higher-dose Osocimab
Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase.
Participants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
|
Lower-dose Osocimab
Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase.
Participants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
|
Placebo
Participants were randomized to receive matching placebo subcutaneously in the same manner as Osocimab.
|
|---|---|---|---|
|
Main Treatment Period
STARTED
|
234
|
235
|
235
|
|
Main Treatment Period
Treated
|
224
|
232
|
230
|
|
Main Treatment Period
COMPLETED
|
194
|
199
|
206
|
|
Main Treatment Period
NOT COMPLETED
|
40
|
36
|
29
|
|
Extension Treatment Period
STARTED
|
194
|
199
|
206
|
|
Extension Treatment Period
COMPLETED
|
174
|
178
|
176
|
|
Extension Treatment Period
NOT COMPLETED
|
20
|
21
|
30
|
Reasons for withdrawal
| Measure |
Higher-dose Osocimab
Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase.
Participants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
|
Lower-dose Osocimab
Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase.
Participants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
|
Placebo
Participants were randomized to receive matching placebo subcutaneously in the same manner as Osocimab.
|
|---|---|---|---|
|
Main Treatment Period
Physician Decision
|
1
|
1
|
0
|
|
Main Treatment Period
Other
|
5
|
2
|
4
|
|
Main Treatment Period
Subject Decision
|
5
|
7
|
3
|
|
Main Treatment Period
Death
|
5
|
11
|
4
|
|
Main Treatment Period
Adverse Event
|
11
|
9
|
9
|
|
Main Treatment Period
Withdrawal by Subject
|
3
|
3
|
4
|
|
Main Treatment Period
Study drug never adminstered
|
10
|
3
|
5
|
|
Extension Treatment Period
Physician Decision
|
1
|
0
|
3
|
|
Extension Treatment Period
Other
|
2
|
6
|
6
|
|
Extension Treatment Period
Subject Decision
|
5
|
2
|
4
|
|
Extension Treatment Period
Death
|
6
|
4
|
7
|
|
Extension Treatment Period
Adverse Event
|
6
|
7
|
9
|
|
Extension Treatment Period
Withdrawal by Subject
|
0
|
1
|
1
|
|
Extension Treatment Period
Study drug never administered
|
0
|
1
|
0
|
Baseline Characteristics
Participants in PDS with evaluable assessment for this measurement.
Baseline characteristics by cohort
| Measure |
Higher-dose Osocimab
n=234 Participants
Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase.
Participants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
|
Lower-dose Osocimab
n=235 Participants
Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase.
Participants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
|
Placebo
n=235 Participants
Participants were randomized to receive matching placebo subcutaneously in the same manner as Osocimab.
|
Total
n=704 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 13.4 • n=234 Participants
|
61.1 years
STANDARD_DEVIATION 12.9 • n=235 Participants
|
59.5 years
STANDARD_DEVIATION 13.3 • n=235 Participants
|
60.5 years
STANDARD_DEVIATION 13.2 • n=704 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=234 Participants
|
90 Participants
n=235 Participants
|
81 Participants
n=235 Participants
|
256 Participants
n=704 Participants
|
|
Sex: Female, Male
Male
|
149 Participants
n=234 Participants
|
145 Participants
n=235 Participants
|
154 Participants
n=235 Participants
|
448 Participants
n=704 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=234 Participants
|
0 Participants
n=235 Participants
|
1 Participants
n=235 Participants
|
2 Participants
n=704 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=234 Participants
|
21 Participants
n=235 Participants
|
21 Participants
n=235 Participants
|
63 Participants
n=704 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=234 Participants
|
1 Participants
n=235 Participants
|
1 Participants
n=235 Participants
|
2 Participants
n=704 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=234 Participants
|
18 Participants
n=235 Participants
|
22 Participants
n=235 Participants
|
59 Participants
n=704 Participants
|
|
Race (NIH/OMB)
White
|
193 Participants
n=234 Participants
|
194 Participants
n=235 Participants
|
190 Participants
n=235 Participants
|
577 Participants
n=704 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=234 Participants
|
1 Participants
n=235 Participants
|
0 Participants
n=235 Participants
|
1 Participants
n=704 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=234 Participants
|
0 Participants
n=235 Participants
|
0 Participants
n=235 Participants
|
0 Participants
n=704 Participants
|
|
Activated partial thromboplastin time (aPTT) value at baseline
|
31.49 seconds
STANDARD_DEVIATION 1.10 • n=209 Participants • Participants in PDS with evaluable assessment for this measurement.
|
31.32 seconds
STANDARD_DEVIATION 1.10 • n=213 Participants • Participants in PDS with evaluable assessment for this measurement.
|
31.65 seconds
STANDARD_DEVIATION 1.09 • n=206 Participants • Participants in PDS with evaluable assessment for this measurement.
|
31.49 seconds
STANDARD_DEVIATION 1.09 • n=628 Participants • Participants in PDS with evaluable assessment for this measurement.
|
|
Factor XI (FXI) activity at baseline
|
100.54 percent
STANDARD_DEVIATION 1.29 • n=208 Participants • Participants in PDS with evaluable assessment for this measurement.
|
102.27 percent
STANDARD_DEVIATION 1.28 • n=212 Participants • Participants in PDS with evaluable assessment for this measurement.
|
103.09 percent
STANDARD_DEVIATION 1.25 • n=202 Participants • Participants in PDS with evaluable assessment for this measurement.
|
101.96 percent
STANDARD_DEVIATION 1.27 • n=622 Participants • Participants in PDS with evaluable assessment for this measurement.
|
PRIMARY outcome
Timeframe: From the first dose of study intervention up till 30 days after last study intervention in the main treatment period, up to 6 monthsPopulation: SAF (Safety analysis set): All participants randomly assigned to study intervention who took at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received.
Cumulative incidence risk of the first Composite of MB and CRNMB (ISTH) at month 6 is reported in the table. Descriptive time to composite of MB and CRNMB Events is reported in statistical analysis. Descriptive time to composite of treatment emergent major and CRNMB events \[in alignment with International Society on Thrombosis and Haemostatsis (ISTH) guidelines\] analyses were performed. The cumulative incidence function for the event-of-interest together with the corresponding confidence interval were estimated for each treatment arm using Aalen-Johansen estimators. Cumulative incidence of events up to the day, inclusive.
Outcome measures
| Measure |
Higher-dose Osocimab
n=224 Participants
Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase.
Participants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
|
Lower-dose Osocimab
n=232 Participants
Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase.
Participants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
|
Placebo
n=230 Participants
Participants were randomized to receive matching placebo subcutaneously in the same manner as Osocimab.
|
|---|---|---|---|
|
Cumulative Incidence Risk of the First Composite of Major Bleeding (MB) and Clinically-relevant Non-major Bleeding (CRNMB) Events as Assessed by Blinded Central Independent Adjudication Committee (CIAC)
|
3.57 Percentage of participants
Interval 1.91 to 6.04
|
4.32 Percentage of participants
Interval 2.48 to 6.91
|
6.09 Percentage of participants
Interval 3.84 to 9.04
|
PRIMARY outcome
Timeframe: From the first dose of study intervention up until 30 days after last study intervention in the main treatment period, up to 6 monthsPopulation: SAF (Safety analysis set)
Cumulative incidence risk of composite of moderate and severe AEs and SAEs at month 6 is reported in the table. Descriptive time to the composite of Moderate and Severe AEs and SAEs is reported in statistical analysis. An AE was any untoward medical occurrence in a patient or clinical study participant, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Higher-dose Osocimab
n=224 Participants
Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase.
Participants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
|
Lower-dose Osocimab
n=232 Participants
Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase.
Participants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
|
Placebo
n=230 Participants
Participants were randomized to receive matching placebo subcutaneously in the same manner as Osocimab.
|
|---|---|---|---|
|
Cumulative Incidence Risk of Composite of Moderate and Severe Adverse Events (AEs) and Serious Adverse Events (SAEs)
|
38.84 Percentage of participants
Interval 33.46 to 44.17
|
38.37 Percentage of participants
Interval 33.1 to 43.6
|
32.17 Percentage of participants
Interval 27.16 to 37.28
|
SECONDARY outcome
Timeframe: At 6 months (Visit 19 / Day 30 of the 6th month)Population: PDS (Pharmacodynamic analysis set): All participants with at least 1 PD sample in accordance with the PD sampling schedule and without deviation from the protocol that would have interfered with the evaluation of the PD data were included in the PD analysis. Participants in PDS with data available for this outcome measure
The aPTT at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation). aPTT was measured via the kaolin-trigger method (clotting assay).
Outcome measures
| Measure |
Higher-dose Osocimab
n=167 Participants
Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase.
Participants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
|
Lower-dose Osocimab
n=174 Participants
Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase.
Participants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
|
Placebo
n=174 Participants
Participants were randomized to receive matching placebo subcutaneously in the same manner as Osocimab.
|
|---|---|---|---|
|
Ratio of Activated Partial Thromboplastin Time (aPTT) at 6 Months Trough Levels Versus Baseline.
|
1.26 Ratio
Standard Deviation 1.11
|
1.19 Ratio
Standard Deviation 1.11
|
1.02 Ratio
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: At 6 months (Visit 19 / Day 30 of the 6th month)Population: PDS (Pharmacodynamic analysis set). Participants in PDS with data available for this outcome measure
The Factor XI (FXI) activity at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation). Factor XI activity was assessed with an aPTT-based coagulation test using FXI deficient plasma.
Outcome measures
| Measure |
Higher-dose Osocimab
n=164 Participants
Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase.
Participants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
|
Lower-dose Osocimab
n=175 Participants
Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase.
Participants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
|
Placebo
n=171 Participants
Participants were randomized to receive matching placebo subcutaneously in the same manner as Osocimab.
|
|---|---|---|---|
|
Ratio of Factor XI (FXI) Activity at 6 Months Trough Levels Versus Baseline
|
0.87 Ratio
Standard Deviation 1.27
|
0.94 Ratio
Standard Deviation 1.23
|
0.96 Ratio
Standard Deviation 1.20
|
Adverse Events
Higher-dose Osocimab
Serious events: 61 serious events
Other events: 90 other events
Deaths: 19 deaths
Lower-dose Osocimab
Serious events: 67 serious events
Other events: 85 other events
Deaths: 24 deaths
Placebo
Serious events: 63 serious events
Other events: 88 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Higher-dose Osocimab
n=224 participants at risk
Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase.
Participants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
|
Lower-dose Osocimab
n=232 participants at risk
Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase.
Participants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
|
Placebo
n=230 participants at risk
Participants were randomized to receive matching placebo subcutaneously in the same manner as Osocimab.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.86%
2/232 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.87%
2/230 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.89%
2/224 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.86%
2/232 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.87%
2/230 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Cardiac disorders
Cardiac arrest
|
0.89%
2/224 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Cardiac disorders
Cardiac failure
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.86%
2/232 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Cardiac disorders
Dressler's syndrome
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
1.3%
3/230 • Number of events 3 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.89%
2/224 • Number of events 3 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Eye disorders
Cataract
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.87%
2/230 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Gastrointestinal disorders
Intestinal dilatation
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Gastrointestinal disorders
Tongue haematoma
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Gastrointestinal disorders
Gastrointestinal wall thickening
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
General disorders
Asthenia
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
General disorders
Chest pain
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.86%
2/232 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
General disorders
Sudden death
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
General disorders
General physical health deterioration
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
General disorders
Cardiac death
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.86%
2/232 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Gangrene
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Infection
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Localised infection
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Osteomyelitis
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Peritonitis
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Pneumonia
|
1.8%
4/224 • Number of events 4 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
1.7%
4/230 • Number of events 4 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Sepsis
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.87%
2/230 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Tuberculous pleurisy
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Urinary tract infection
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.86%
2/232 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.87%
2/230 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Febrile infection
|
0.45%
1/224 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Arteriovenous fistula site infection
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Renal cyst infection
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Device related infection
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Vascular access site infection
|
0.89%
2/224 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
COVID-19
|
3.1%
7/224 • Number of events 7 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
3.4%
8/232 • Number of events 8 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
2.2%
5/230 • Number of events 5 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.3%
3/224 • Number of events 3 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
3.9%
9/232 • Number of events 9 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
3.5%
8/230 • Number of events 8 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Device related bacteraemia
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.45%
1/224 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
1.3%
3/230 • Number of events 3 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Shunt aneurysm
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.45%
1/224 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Unintentional medical device removal
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Injury, poisoning and procedural complications
Vascular access site inflammation
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Investigations
Angiocardiogram
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.86%
2/232 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Nervous system disorders
Ischaemic stroke
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Psychiatric disorders
Mental status changes
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.86%
2/232 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Renal and urinary disorders
Nephrosclerosis
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Renal and urinary disorders
Renal haematoma
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Renal and urinary disorders
Renal cyst ruptured
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.89%
2/224 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Surgical and medical procedures
Parathyroidectomy
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Surgical and medical procedures
Renal transplant
|
2.2%
5/224 • Number of events 5 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
1.3%
3/232 • Number of events 3 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
2.2%
5/230 • Number of events 5 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Surgical and medical procedures
Toe amputation
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Surgical and medical procedures
Central venous catheterisation
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Surgical and medical procedures
Intervertebral disc operation
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Surgical and medical procedures
Dialysis device insertion
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Surgical and medical procedures
Arteriovenous graft
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Surgical and medical procedures
Bladder neoplasm surgery
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Surgical and medical procedures
Peritoneal catheter insertion
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Vascular disorders
Hypertension
|
1.3%
3/224 • Number of events 3 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Vascular disorders
Iliac artery dissection
|
0.45%
1/224 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/232 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/230 • Number of events 2 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Vascular disorders
Peripheral vein occlusion
|
0.00%
0/224 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.43%
1/232 • Number of events 1 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
0.00%
0/230 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
Other adverse events
| Measure |
Higher-dose Osocimab
n=224 participants at risk
Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase.
Participants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
|
Lower-dose Osocimab
n=232 participants at risk
Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase.
Participants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
|
Placebo
n=230 participants at risk
Participants were randomized to receive matching placebo subcutaneously in the same manner as Osocimab.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.5%
10/224 • Number of events 10 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
5.2%
12/232 • Number of events 12 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
5.2%
12/230 • Number of events 13 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
13/224 • Number of events 16 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
2.6%
6/232 • Number of events 6 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
7.0%
16/230 • Number of events 18 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
7/224 • Number of events 7 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
3.4%
8/232 • Number of events 10 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
5.2%
12/230 • Number of events 16 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
General disorders
Pyrexia
|
6.2%
14/224 • Number of events 15 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
3.9%
9/232 • Number of events 12 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
6.1%
14/230 • Number of events 17 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Infections and infestations
COVID-19
|
4.9%
11/224 • Number of events 11 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
6.0%
14/232 • Number of events 14 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
5.2%
12/230 • Number of events 12 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.4%
12/224 • Number of events 20 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
3.9%
9/232 • Number of events 17 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
6.5%
15/230 • Number of events 23 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Nervous system disorders
Headache
|
8.5%
19/224 • Number of events 21 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
9.9%
23/232 • Number of events 26 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
6.1%
14/230 • Number of events 15 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Vascular disorders
Hypertension
|
8.0%
18/224 • Number of events 20 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
7.8%
18/232 • Number of events 24 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
7.0%
16/230 • Number of events 17 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
|
Vascular disorders
Hypotension
|
6.7%
15/224 • Number of events 22 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
5.6%
13/232 • Number of events 27 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
7.8%
18/230 • Number of events 28 • After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee It's typically 30 days to review, and only if there is some need to file a patent application based on that review would there be an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER