Trial Outcomes & Findings for Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF (NCT NCT03547583)
NCT ID: NCT03547583
Last Updated: 2021-01-06
Results Overview
The City Cardiomyopathy Questionnaire (KCCQ) measures the impact of patients' heart failure, or its treatment, on 6 domains; Physical Limitation, Symptom (with subscores for frequency and burden), Quality of Life, Social Limitations, Symptom Stability and Self-Efficacy. Scores are calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
789 participants
Primary outcome timeframe
From baseline to Week 24
Results posted on
2021-01-06
Participant Flow
Study was conducted at 178 study centers worldwide, between 15-Jun-2018 (first subject first visit) and 04-Nov-2019 (last subject last visit).
Overall, 979 participants were screened, of whom 789 participants were randomized in the study. 788 of the randomized participants were allocated to study treatment, of whom 672 participants completed the study.
Participant milestones
| Measure |
Vericiguat up to 10 mg
Participants received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.
|
Vericiguat up to 15 mg
Participants received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6 week.
|
Placebo
Participants received placebo once daily and sham up-titration at weeks 2, 4, and 6.
|
|---|---|---|---|
|
Overall Study
STARTED
|
263
|
264
|
262
|
|
Overall Study
Treated
|
262
|
264
|
262
|
|
Overall Study
COMPLETED
|
218
|
224
|
230
|
|
Overall Study
NOT COMPLETED
|
45
|
40
|
32
|
Reasons for withdrawal
| Measure |
Vericiguat up to 10 mg
Participants received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.
|
Vericiguat up to 15 mg
Participants received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6 week.
|
Placebo
Participants received placebo once daily and sham up-titration at weeks 2, 4, and 6.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
16
|
11
|
10
|
|
Overall Study
Death
|
11
|
7
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Non-compliance with study drug
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
3
|
|
Overall Study
Protocol Violation
|
2
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
12
|
19
|
10
|
|
Overall Study
Other
|
2
|
2
|
3
|
Baseline Characteristics
The participants in FAS 6MWT were analyzed for this outcome measure.
Baseline characteristics by cohort
| Measure |
Vericiguat up to 10 mg
n=263 Participants
Participants received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.
|
Vericiguat up to 15 mg
n=264 Participants
Participants received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6 week.
|
Placebo
n=262 Participants
Participants received placebo once daily and sham up-titration at weeks 2, 4, and 6.
|
Total
n=789 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
72.2 years
STANDARD_DEVIATION 9.7 • n=263 Participants
|
73.1 years
STANDARD_DEVIATION 9.1 • n=264 Participants
|
72.8 years
STANDARD_DEVIATION 9.4 • n=262 Participants
|
72.7 years
STANDARD_DEVIATION 9.4 • n=789 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=263 Participants
|
140 Participants
n=264 Participants
|
121 Participants
n=262 Participants
|
385 Participants
n=789 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=263 Participants
|
124 Participants
n=264 Participants
|
141 Participants
n=262 Participants
|
404 Participants
n=789 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=263 Participants
|
21 Participants
n=264 Participants
|
23 Participants
n=262 Participants
|
72 Participants
n=789 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
235 Participants
n=263 Participants
|
242 Participants
n=264 Participants
|
238 Participants
n=262 Participants
|
715 Participants
n=789 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=263 Participants
|
1 Participants
n=264 Participants
|
1 Participants
n=262 Participants
|
2 Participants
n=789 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=263 Participants
|
4 Participants
n=264 Participants
|
4 Participants
n=262 Participants
|
11 Participants
n=789 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=263 Participants
|
26 Participants
n=264 Participants
|
25 Participants
n=262 Participants
|
75 Participants
n=789 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=263 Participants
|
0 Participants
n=264 Participants
|
0 Participants
n=262 Participants
|
0 Participants
n=789 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=263 Participants
|
7 Participants
n=264 Participants
|
9 Participants
n=262 Participants
|
21 Participants
n=789 Participants
|
|
Race (NIH/OMB)
White
|
228 Participants
n=263 Participants
|
224 Participants
n=264 Participants
|
222 Participants
n=262 Participants
|
674 Participants
n=789 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=263 Participants
|
2 Participants
n=264 Participants
|
2 Participants
n=262 Participants
|
6 Participants
n=789 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=263 Participants
|
1 Participants
n=264 Participants
|
0 Participants
n=262 Participants
|
2 Participants
n=789 Participants
|
|
Six-minute walk test
|
292.13 Meters
STANDARD_DEVIATION 107.75 • n=236 Participants • The participants in FAS 6MWT were analyzed for this outcome measure.
|
294.99 Meters
STANDARD_DEVIATION 118.00 • n=245 Participants • The participants in FAS 6MWT were analyzed for this outcome measure.
|
295.80 Meters
STANDARD_DEVIATION 106.27 • n=240 Participants • The participants in FAS 6MWT were analyzed for this outcome measure.
|
294.32 Meters
STANDARD_DEVIATION 110.72 • n=721 Participants • The participants in FAS 6MWT were analyzed for this outcome measure.
|
|
Kansas City Cardiopathy Questionnaire Physical limitation score (KCCQ PLS)
|
57.30 Scores
STANDARD_DEVIATION 24.77 • n=254 Participants • The participants in FAS KCCQ were analyzed for this outcome measure.
|
60.03 Scores
STANDARD_DEVIATION 24.64 • n=255 Participants • The participants in FAS KCCQ were analyzed for this outcome measure.
|
59.03 Scores
STANDARD_DEVIATION 24.00 • n=252 Participants • The participants in FAS KCCQ were analyzed for this outcome measure.
|
58.79 Scores
STANDARD_DEVIATION 24.46 • n=761 Participants • The participants in FAS KCCQ were analyzed for this outcome measure.
|
PRIMARY outcome
Timeframe: From baseline to Week 24Population: FAS KCCQ: All patients randomized and treated (at least one dose of the study treatment), and had at least one observed KCCQ PLS assessment at both baseline and during post-baseline (excluding safety follow-up) were valid for this analysis set.
The City Cardiomyopathy Questionnaire (KCCQ) measures the impact of patients' heart failure, or its treatment, on 6 domains; Physical Limitation, Symptom (with subscores for frequency and burden), Quality of Life, Social Limitations, Symptom Stability and Self-Efficacy. Scores are calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.
Outcome measures
| Measure |
Vericiguat up to 10 mg
n=254 Participants
Participants received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.
|
Vericiguat up to 15 mg
n=255 Participants
Participants received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6 week.
|
Placebo
n=252 Participants
Participants received placebo once daily and sham up-titration at weeks 2, 4, and 6.
|
|---|---|---|---|
|
Change in KCCQ Physical Limitation Score From Baseline to Week 24
|
6.41 Scores on a scale
Standard Error 1.592
|
5.47 Scores on a scale
Standard Error 1.538
|
6.93 Scores on a scale
Standard Error 1.535
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: FAS 6MWT: All patients randomized and treated (at least one dose of the study treatment), and who were able to perform at least one 6MWT assessment at both baseline and post-baseline (excluding safety follow-up) were valid for this analysis set.
6MWT was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured.
Outcome measures
| Measure |
Vericiguat up to 10 mg
n=236 Participants
Participants received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.
|
Vericiguat up to 15 mg
n=245 Participants
Participants received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6 week.
|
Placebo
n=240 Participants
Participants received placebo once daily and sham up-titration at weeks 2, 4, and 6.
|
|---|---|---|---|
|
Change in the Six-minute Walk Test (6MWT) From Baseline to Week 24
|
8.68 Meters
Standard Error 5.841
|
5.00 Meters
Standard Error 5.718
|
10.49 Meters
Standard Error 5.512
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From first application of study drug up to 5 calendar days after end of treatment with study drugAn AE is any untoward medical occurrence (i.e. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a patient or clinical investigation patient after providing written informed consent for participation in the study. Adverse events are considered to be treatment-emergent if they have started or worsened after first application of study medication up to 5 calendar days after end of treatment with study medication.
Outcome measures
| Measure |
Vericiguat up to 10 mg
n=262 Participants
Participants received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.
|
Vericiguat up to 15 mg
n=264 Participants
Participants received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6 week.
|
Placebo
n=262 Participants
Participants received placebo once daily and sham up-titration at weeks 2, 4, and 6.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
Any TEAE
|
163 Participants
|
172 Participants
|
172 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Any study drug related TEAE
|
38 Participants
|
42 Participants
|
24 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Any TESAE
|
46 Participants
|
54 Participants
|
48 Participants
|
Adverse Events
Vericiguat up to 10 mg
Serious events: 46 serious events
Other events: 121 other events
Deaths: 15 deaths
Vericiguat up to 15 mg
Serious events: 54 serious events
Other events: 134 other events
Deaths: 10 deaths
Placebo
Serious events: 48 serious events
Other events: 131 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Vericiguat up to 10 mg
n=262 participants at risk
Subjects received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.
|
Vericiguat up to 15 mg
n=264 participants at risk
Subjects received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6.
|
Placebo
n=262 participants at risk
Subjects received placebo for 24 weeks, once daily, starting sham up-titration at weeks 2, 4, and 6.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Pneumonia
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
2.7%
7/264 • Number of events 7 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Tracheobronchitis
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Septic shock
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/264 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
4/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/264 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Cardiac disorders
Cardiovascular disorder
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Cardiac disorders
Coronary artery disease
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/264 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Cardiac disorders
Sinus node dysfunction
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Eye disorders
Diplopia
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Eye disorders
Macular oedema
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Gastritis
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/264 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Nausea
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Proctitis
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
General disorders
Chest pain
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
General disorders
Death
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
General disorders
Pelvic mass
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
General disorders
Sudden death
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
General disorders
Sudden cardiac death
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Bronchitis
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/264 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Cystitis
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/264 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Localised infection
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Urosepsis
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Groin abscess
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Pulmonary sepsis
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Implant site infection
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Pneumonia bacterial
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Medical device site joint infection
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Injury, poisoning and procedural complications
Scrotal haematoma
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Injury, poisoning and procedural complications
Vulvovaginal injury
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Investigations
Transaminases increased
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Investigations
Angiocardiogram
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.76%
2/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phaeochromocytoma
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Nervous system disorders
Diabetic neuropathy
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Nervous system disorders
Sciatica
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Nervous system disorders
Syncope
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/264 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/264 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/264 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/264 • Number of events 6 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Surgical and medical procedures
Leg amputation
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Vascular disorders
Aortic stenosis
|
0.38%
1/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Vascular disorders
Hypertension
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Vascular disorders
Hypotension
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/264 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Vascular disorders
Peripheral ischaemia
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Product Issues
Device malfunction
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
Other adverse events
| Measure |
Vericiguat up to 10 mg
n=262 participants at risk
Subjects received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.
|
Vericiguat up to 15 mg
n=264 participants at risk
Subjects received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6.
|
Placebo
n=262 participants at risk
Subjects received placebo for 24 weeks, once daily, starting sham up-titration at weeks 2, 4, and 6.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
6/262 • Number of events 6 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
4.9%
13/264 • Number of events 13 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
3.4%
9/262 • Number of events 9 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Cardiac disorders
Atrial fibrillation
|
2.7%
7/262 • Number of events 8 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
2.7%
7/264 • Number of events 9 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
2.3%
6/262 • Number of events 6 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Cardiac disorders
Palpitations
|
1.5%
4/262 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/264 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/264 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
5/262 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
2.3%
6/262 • Number of events 6 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Constipation
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
3.0%
8/264 • Number of events 9 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/262 • Number of events 6 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.9%
5/264 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.9%
5/262 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Dyspepsia
|
1.5%
4/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
2.3%
6/264 • Number of events 7 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/264 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Nausea
|
3.1%
8/262 • Number of events 10 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/264 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
3/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/264 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
General disorders
Asthenia
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
General disorders
Chest pain
|
0.76%
2/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/264 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
General disorders
Fatigue
|
1.1%
3/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
2.7%
7/264 • Number of events 8 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
General disorders
Oedema
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/264 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
General disorders
Oedema peripheral
|
6.1%
16/262 • Number of events 17 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
3.8%
10/264 • Number of events 13 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
3.1%
8/262 • Number of events 10 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
General disorders
Pyrexia
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/264 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.9%
5/262 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Bronchitis
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.9%
5/264 • Number of events 6 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
2.7%
7/262 • Number of events 7 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Gastroenteritis
|
1.5%
4/262 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.9%
5/264 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Influenza
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/264 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
8/262 • Number of events 9 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
2.7%
7/264 • Number of events 7 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
2.7%
7/262 • Number of events 7 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Pneumonia
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/264 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.9%
5/262 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/264 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
2.3%
6/262 • Number of events 6 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Urinary tract infection
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
2.3%
6/264 • Number of events 6 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Respiratory tract infection viral
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Infections and infestations
Respiratory tract infection
|
1.9%
5/262 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
2.7%
7/264 • Number of events 7 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/262 • Number of events 6 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
4/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/264 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/264 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Investigations
Blood creatinine increased
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/264 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Investigations
Blood uric acid increased
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/264 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Investigations
Weight decreased
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/264 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Investigations
N-terminal prohormone brain natriuretic peptide increased
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/262 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.9%
5/262 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
2.7%
7/264 • Number of events 7 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
4.6%
12/262 • Number of events 13 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.7%
7/262 • Number of events 7 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
3.0%
8/264 • Number of events 9 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/264 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.9%
5/262 • Number of events 7 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
2.7%
7/264 • Number of events 8 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
3.1%
8/262 • Number of events 8 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/264 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.9%
5/264 • Number of events 6 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
3.1%
8/262 • Number of events 10 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
5/262 • Number of events 6 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/264 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.9%
5/262 • Number of events 6 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/264 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/264 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.38%
1/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/264 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Nervous system disorders
Dizziness
|
3.1%
8/262 • Number of events 9 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
2.7%
7/264 • Number of events 9 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
4.2%
11/262 • Number of events 14 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Nervous system disorders
Headache
|
1.9%
5/262 • Number of events 6 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
2.3%
6/264 • Number of events 7 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
4.2%
11/262 • Number of events 16 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Nervous system disorders
Tremor
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/264 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Psychiatric disorders
Anxiety
|
1.1%
3/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/264 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Psychiatric disorders
Insomnia
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/264 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Renal and urinary disorders
Renal failure
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/264 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Renal and urinary disorders
Renal impairment
|
1.9%
5/262 • Number of events 6 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.5%
4/264 • Number of events 7 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.9%
5/262 • Number of events 7 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.38%
1/262 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.38%
1/264 • Number of events 1 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/264 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
2.7%
7/262 • Number of events 9 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/264 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
5/262 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.9%
5/264 • Number of events 6 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
2.3%
6/262 • Number of events 6 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
7/262 • Number of events 8 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.9%
5/264 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
5.3%
14/262 • Number of events 15 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
3/262 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.9%
5/264 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/262 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.76%
2/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/264 • Number of events 3 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.00%
0/262 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
3/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/264 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
2.3%
6/262 • Number of events 8 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Surgical and medical procedures
Cataract operation
|
0.38%
1/262 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
0.76%
2/264 • Number of events 2 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
1.1%
3/262 • Number of events 4 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Vascular disorders
Hypertension
|
1.9%
5/262 • Number of events 5 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
4.2%
11/264 • Number of events 12 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
3.8%
10/262 • Number of events 12 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
|
Vascular disorders
Hypotension
|
6.1%
16/262 • Number of events 18 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
8.3%
22/264 • Number of events 31 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
4.6%
12/262 • Number of events 14 • Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication. Timeframe for number of death (all causes): After study medication start until last contact date. (The median follow-up time is 197 days.)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER