Trial Outcomes & Findings for Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure and Preserved Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-PRESERVED) (NCT NCT01951638)
NCT ID: NCT01951638
Last Updated: 2021-03-16
Results Overview
NTproBNP is a circulating plasma biomarker of cardiovascular function and prognosis in heart failure (HF).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
477 participants
Primary outcome timeframe
Baseline, Week 12 (end of treatment [EOT])
Results posted on
2021-03-16
Participant Flow
The study was conducted at 158 centers in 25 countries between 06 November 2013 (first subject first visit) and 16 September 2015 (last subject last visit).
Overall, 632 subjects were enrolled, of them 477 were randomized and 475 were treated. Among the 477 subjects who were randomized, 404 subjects completed both treatment and follow-up \[FU\] periods. All arms in FU period were mutually exclusive, this question below is ticked No because of database validation rule constraints.
Participant milestones
| Measure |
Placebo
Subjects received placebo matched to vericiguat (BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 1.25 mg
Subjects received vericiguat (Verquvo, BAY1021189) 1.25 milligram (mg) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 2.5 mg
Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 2.5 mg to 5 mg
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg after 14 or 28 days. Sham titration included on Day 28.
|
BAY1021189 2.5 mg to 10 mg
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days.
|
|---|---|---|---|---|---|
|
Treatment Period
STARTED
|
93
|
96
|
96
|
96
|
96
|
|
Treatment Period
COMPLETED
|
80
|
82
|
83
|
80
|
86
|
|
Treatment Period
NOT COMPLETED
|
13
|
14
|
13
|
16
|
10
|
|
Follow-up Period
STARTED
|
89
|
95
|
95
|
88
|
94
|
|
Follow-up Period
COMPLETED
|
87
|
86
|
90
|
80
|
89
|
|
Follow-up Period
NOT COMPLETED
|
2
|
9
|
5
|
8
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Subjects received placebo matched to vericiguat (BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 1.25 mg
Subjects received vericiguat (Verquvo, BAY1021189) 1.25 milligram (mg) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 2.5 mg
Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 2.5 mg to 5 mg
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg after 14 or 28 days. Sham titration included on Day 28.
|
BAY1021189 2.5 mg to 10 mg
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days.
|
|---|---|---|---|---|---|
|
Treatment Period
Protocol Violation
|
0
|
0
|
0
|
2
|
0
|
|
Treatment Period
Protocol-driven decision point
|
1
|
3
|
0
|
0
|
0
|
|
Treatment Period
Logistical difficulties
|
0
|
1
|
1
|
0
|
0
|
|
Treatment Period
Withdrawal by Subject
|
9
|
6
|
4
|
5
|
4
|
|
Treatment Period
Death
|
0
|
0
|
0
|
3
|
1
|
|
Treatment Period
Adverse Event
|
3
|
4
|
8
|
6
|
5
|
|
Follow-up Period
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
|
Follow-up Period
Logistical difficulties
|
0
|
2
|
0
|
0
|
1
|
|
Follow-up Period
Withdrawal by Subject
|
1
|
5
|
2
|
1
|
2
|
|
Follow-up Period
Lost to Follow-up
|
0
|
1
|
0
|
1
|
0
|
|
Follow-up Period
Death
|
1
|
0
|
1
|
4
|
1
|
|
Follow-up Period
Adverse Event
|
0
|
1
|
2
|
1
|
1
|
Baseline Characteristics
Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure and Preserved Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-PRESERVED)
Baseline characteristics by cohort
| Measure |
BAY1021189 1.25 mg
n=96 Participants
Subjects received vericiguat (Verquvo, BAY1021189) 1.25 milligram (mg) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
Placebo
n=93 Participants
Subjects received placebo matched to vericiguat (BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 2.5 mg
n=96 Participants
Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 2.5 mg to 5 mg
n=96 Participants
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg after 14 or 28 days. Sham titration included on Day 28.
|
BAY1021189 2.5 mg to 10 mg
n=96 Participants
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days.
|
Total
n=477 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
73.8 years
STANDARD_DEVIATION 10 • n=5 Participants
|
73.7 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
72 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
73.9 years
STANDARD_DEVIATION 7.9 • n=4 Participants
|
72.5 years
STANDARD_DEVIATION 10.2 • n=21 Participants
|
73.2 years
STANDARD_DEVIATION 9.6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
227 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
250 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12 (end of treatment [EOT])Population: Per Protocol Set (PPS) NT-pro BNP: included all subjects randomized to treatment who had a valid measurement of NT-pro BNP at baseline and at Week 12 (Visit 5) and showed no major protocol deviations.
NTproBNP is a circulating plasma biomarker of cardiovascular function and prognosis in heart failure (HF).
Outcome measures
| Measure |
Placebo
n=73 Participants
Subjects received placebo matched to vericiguat (BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 1.25 mg
n=77 Participants
Subjects received vericiguat (Verquvo, BAY1021189) 1.25 milligram (mg) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 2.5 mg
n=78 Participants
Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 2.5 mg to 5 mg
n=57 Participants
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg after 14 or 28 days. Sham titration included on Day 28.
|
BAY1021189 2.5 mg to 10 mg
n=60 Participants
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days.
|
|---|---|---|---|---|---|
|
Change From Baseline to Week 12 in Log-transformed N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
|
-0.098 log-transformed picograms per milliliter
Standard Deviation 0.778
|
-0.047 log-transformed picograms per milliliter
Standard Deviation 0.788
|
0.071 log-transformed picograms per milliliter
Standard Deviation 0.818
|
0.057 log-transformed picograms per milliliter
Standard Deviation 0.819
|
-0.023 log-transformed picograms per milliliter
Standard Deviation 0.705
|
PRIMARY outcome
Timeframe: Baseline, Week 12 (EOT)Population: PPS Left Atrial Volume (LAV) included all subjects randomized to treatment who had a valid measurement of LAV at baseline and at Week 12 (Visit 5) and showed no major protocol deviations.
Left atrial volume was measured by echocardiography.
Outcome measures
| Measure |
Placebo
n=67 Participants
Subjects received placebo matched to vericiguat (BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 1.25 mg
n=77 Participants
Subjects received vericiguat (Verquvo, BAY1021189) 1.25 milligram (mg) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 2.5 mg
n=78 Participants
Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 2.5 mg to 5 mg
n=57 Participants
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg after 14 or 28 days. Sham titration included on Day 28.
|
BAY1021189 2.5 mg to 10 mg
n=59 Participants
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days.
|
|---|---|---|---|---|---|
|
Change From Baseline to Week 12 in Left Atrial Volume (LAV)
|
-3.361 milliliter
Standard Deviation 12.654 • Interval 12.654 to
|
-2.163 milliliter
Standard Deviation 7.895 • Interval 7.895 to
|
-2.142 milliliter
Standard Deviation 11.931 • Interval 11.931 to
|
-1.252 milliliter
Standard Deviation 16.139 • Interval 16.139 to
|
-1.654 milliliter
Standard Deviation 10.245 • Interval 10.245 to
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12 (EOT)Population: Safety Analysis Set (SAF) with evaluable subjects for this endpoint.
Blood pressure was measured after at least 10 minutes resting in a sitting position (3 measurements taken approximately 2 minutes apart).The changes in blood pressure were recorded and the mean of the three measurements was analyzed.
Outcome measures
| Measure |
Placebo
n=80 Participants
Subjects received placebo matched to vericiguat (BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 1.25 mg
n=82 Participants
Subjects received vericiguat (Verquvo, BAY1021189) 1.25 milligram (mg) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 2.5 mg
n=83 Participants
Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 2.5 mg to 5 mg
n=61 Participants
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg after 14 or 28 days. Sham titration included on Day 28.
|
BAY1021189 2.5 mg to 10 mg
n=61 Participants
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days.
|
|---|---|---|---|---|---|
|
Change From Baseline to Week 12 Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Change in SBP
|
1.458 millimeter of mercury
Standard Deviation 18.865
|
0.703 millimeter of mercury
Standard Deviation 16.993
|
-1.819 millimeter of mercury
Standard Deviation 19.438
|
-1.486 millimeter of mercury
Standard Deviation 17.179
|
-0.913 millimeter of mercury
Standard Deviation 15.498
|
|
Change From Baseline to Week 12 Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Change in DBP
|
1.887 millimeter of mercury
Standard Deviation 11.435
|
0.911 millimeter of mercury
Standard Deviation 10.037
|
-2.173 millimeter of mercury
Standard Deviation 11.249
|
-1.142 millimeter of mercury
Standard Deviation 11.4
|
-0.629 millimeter of mercury
Standard Deviation 10.271
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12 (EOT)Population: Safety Analysis Set (SAF) with evaluable subjects for this endpoint.
Heart rate was measured after 10 minutes resting in a sitting position (3 measurements taken approximatly 2 minutes apart). The changes in heart rate were recorded and the mean of the three measurements was analyzed.
Outcome measures
| Measure |
Placebo
n=80 Participants
Subjects received placebo matched to vericiguat (BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 1.25 mg
n=82 Participants
Subjects received vericiguat (Verquvo, BAY1021189) 1.25 milligram (mg) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 2.5 mg
n=83 Participants
Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 2.5 mg to 5 mg
n=61 Participants
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg after 14 or 28 days. Sham titration included on Day 28.
|
BAY1021189 2.5 mg to 10 mg
n=61 Participants
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days.
|
|---|---|---|---|---|---|
|
Change From Baseline to Week 12 in Heart Rate
|
3.287 beats per minute
Standard Deviation 13.582 • Interval 13.582 to
|
1.776 beats per minute
Standard Deviation 11.42 • Interval 11.42 to
|
-0.373 beats per minute
Standard Deviation 9.845 • Interval 9.845 to
|
1.055 beats per minute
Standard Deviation 13.331 • Interval 13.331 to
|
-2.623 beats per minute
Standard Deviation 9.639 • Interval 9.639 to
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 16 including 12 week treatment period and 4 week follow-up periodPopulation: Full Analysis Set (FAS) included all subjects who were randomized to treatment.
Clinical events (heart failure and mortality) were analyzed as CV death, and HF hospitalization at specified time points.
Outcome measures
| Measure |
Placebo
n=93 Participants
Subjects received placebo matched to vericiguat (BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 1.25 mg
n=96 Participants
Subjects received vericiguat (Verquvo, BAY1021189) 1.25 milligram (mg) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 2.5 mg
n=96 Participants
Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 2.5 mg to 5 mg
n=96 Participants
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg after 14 or 28 days. Sham titration included on Day 28.
|
BAY1021189 2.5 mg to 10 mg
n=96 Participants
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days.
|
|---|---|---|---|---|---|
|
Number of Subjects With Clinical Events (Heart Failure Hospitalization and Cardio-vascular [CV] Mortality)
HF hospitalizations
|
8 Participants
|
6 Participants
|
11 Participants
|
8 Participants
|
5 Participants
|
|
Number of Subjects With Clinical Events (Heart Failure Hospitalization and Cardio-vascular [CV] Mortality)
CV Mortality
|
1 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 20 serious events
Other events: 21 other events
Deaths: 1 deaths
BAY1021189 1.25 mg
Serious events: 20 serious events
Other events: 33 other events
Deaths: 0 deaths
BAY1021189 2.5 mg
Serious events: 24 serious events
Other events: 40 other events
Deaths: 1 deaths
BAY1021189 From 2.5 to 5 mg
Serious events: 18 serious events
Other events: 38 other events
Deaths: 7 deaths
BAY1021189 From 2.5 to 10 mg
Serious events: 21 serious events
Other events: 33 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Placebo
n=93 participants at risk
Subjects received placebo matched to vericiguat (BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 1.25 mg
n=96 participants at risk
Subjects received vericiguat (Verquvo, BAY1021189) 1.25 milligram (mg) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 2.5 mg
n=95 participants at risk
Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 From 2.5 to 5 mg
n=95 participants at risk
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28.
|
BAY1021189 From 2.5 to 10 mg
n=96 participants at risk
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
2/93 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Cardiac disorders
Angina unstable
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
2.1%
2/95 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Cardiac disorders
Cardiac failure
|
6.5%
6/93 • Number of events 6 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
4.2%
4/96 • Number of events 4 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
7.4%
7/95 • Number of events 12 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
5.3%
5/95 • Number of events 8 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
2.1%
2/96 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Cardiac disorders
Cardiac failure acute
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
3.2%
3/95 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Cardiac disorders
Cardiac failure chronic
|
2.2%
2/93 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
4.2%
4/96 • Number of events 4 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
3.2%
3/95 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
2.1%
2/95 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
4.2%
4/96 • Number of events 5 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Cardiac disorders
Cardiac failure congestive
|
2.2%
2/93 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
3.2%
3/95 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
2.1%
2/96 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Eye disorders
Vitreous haemorrhage
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
General disorders
Chest pain
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
General disorders
Pain
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
General disorders
Pyrexia
|
1.1%
1/93 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
General disorders
Sudden death
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Infections and infestations
Carbuncle
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Infections and infestations
Erysipelas
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Infections and infestations
Gangrene
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Infections and infestations
Gastroenteritis
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Infections and infestations
Pneumonia
|
1.1%
1/93 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
3.1%
3/96 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Infections and infestations
Urosepsis
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Infections and infestations
Urinary tract infection bacterial
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Infections and infestations
Enterococcal sepsis
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Infections and infestations
Respiratory tract infection
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Investigations
Coagulation time prolonged
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Investigations
Intraocular pressure increased
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Nervous system disorders
Presyncope
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Nervous system disorders
Syncope
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Nervous system disorders
Cervicogenic headache
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
2/93 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
4.2%
4/95 • Number of events 4 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
3.1%
3/96 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
2.1%
2/96 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Surgical and medical procedures
Eyelid operation
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Vascular disorders
Hypotension
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Vascular disorders
Orthostatic hypotension
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
Other adverse events
| Measure |
Placebo
n=93 participants at risk
Subjects received placebo matched to vericiguat (BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 1.25 mg
n=96 participants at risk
Subjects received vericiguat (Verquvo, BAY1021189) 1.25 milligram (mg) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 2.5 mg
n=95 participants at risk
Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
|
BAY1021189 From 2.5 to 5 mg
n=95 participants at risk
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28.
|
BAY1021189 From 2.5 to 10 mg
n=96 participants at risk
Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
5.4%
5/93 • Number of events 5 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
3.2%
3/95 • Number of events 4 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
3.2%
3/95 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
2.1%
2/96 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
5.3%
5/95 • Number of events 5 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
2.1%
2/95 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Gastrointestinal disorders
Nausea
|
2.2%
2/93 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
2.1%
2/96 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
4.2%
4/95 • Number of events 5 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
5.3%
5/95 • Number of events 5 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
4.2%
4/96 • Number of events 5 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
General disorders
Fatigue
|
2.2%
2/93 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
2.1%
2/96 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
3.2%
3/95 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
6.3%
6/95 • Number of events 6 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
4.2%
4/96 • Number of events 4 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
General disorders
Oedema peripheral
|
2.2%
2/93 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
3.1%
3/96 • Number of events 4 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
2.1%
2/95 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
6.3%
6/95 • Number of events 7 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Infections and infestations
Bronchitis
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
2.1%
2/95 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
4.2%
4/95 • Number of events 4 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
6.2%
6/96 • Number of events 6 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
3/93 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
4.2%
4/96 • Number of events 4 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
6.3%
6/95 • Number of events 8 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
5.2%
5/96 • Number of events 5 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/93 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
6.2%
6/96 • Number of events 6 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
2.1%
2/95 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
3.2%
3/95 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
3.1%
3/96 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Nervous system disorders
Dizziness
|
3.2%
3/93 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
2.1%
2/96 • Number of events 4 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
10.5%
10/95 • Number of events 11 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
6.3%
6/95 • Number of events 6 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
7.3%
7/96 • Number of events 7 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Nervous system disorders
Headache
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
6.3%
6/95 • Number of events 6 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
4.2%
4/95 • Number of events 4 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
4.2%
4/96 • Number of events 4 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Renal and urinary disorders
Renal failure
|
2.2%
2/93 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
5.2%
5/96 • Number of events 5 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.1%
1/95 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/96 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
0.00%
0/95 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
5.3%
5/95 • Number of events 5 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
1.0%
1/96 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
5.2%
5/96 • Number of events 5 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
6.3%
6/95 • Number of events 6 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
2.1%
2/95 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
2.1%
2/96 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.2%
3/93 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
6.2%
6/96 • Number of events 7 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
9.5%
9/95 • Number of events 10 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
5.3%
5/95 • Number of events 6 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
3.1%
3/96 • Number of events 3 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
|
Vascular disorders
Hypotension
|
1.1%
1/93 • Number of events 1 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
4.2%
4/96 • Number of events 4 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
4.2%
4/95 • Number of events 6 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
5.3%
5/95 • Number of events 5 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
2.1%
2/96 • Number of events 2 • Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place