Trial Outcomes & Findings for Firibastat or Ramipril After Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction (NCT NCT03715998)
NCT ID: NCT03715998
Last Updated: 2023-02-27
Results Overview
Comparison of the effects of BID oral administration of 2 doses of firibastat to those of BID oral administration of ramipril on the change from Baseline in LVEF on Day 84
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
295 participants
Primary outcome timeframe
84 days
Results posted on
2023-02-27
Participant Flow
Participant milestones
| Measure |
Group 1: Firibastat 100 mg
Subjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks.
Firibastat: 1 or 2 capsules administered orally, twice daily
|
Group 2: Firibastat 500 mg
Subjects will receive 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks.
Firibastat: 1 or 2 capsules administered orally, twice daily
|
Group 3: Ramipril 2.5 mg
Subjects will receive 5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks.
Ramipril: 1 or 2 capsules administered orally, twice daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
98
|
99
|
98
|
|
Overall Study
COMPLETED
|
81
|
80
|
88
|
|
Overall Study
NOT COMPLETED
|
17
|
19
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age analyzed on mITT population.
Baseline characteristics by cohort
| Measure |
Group 1: Firibastat 100 mg
n=98 Participants
Subjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks.
Firibastat: 1 or 2 capsules administered orally, twice daily
|
Group 2: Firibastat 500 mg
n=99 Participants
Subjects will receive 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks.
Firibastat: 1 or 2 capsules administered orally, twice daily
|
Group 3: Ramipril 5 mg
n=98 Participants
Subjects will receive 2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks.
Ramipril: 1 or 2 capsules administered orally, twice daily
|
Total
n=295 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=72 Participants • Age analyzed on mITT population.
|
0 Participants
n=77 Participants • Age analyzed on mITT population.
|
0 Participants
n=80 Participants • Age analyzed on mITT population.
|
0 Participants
n=229 Participants • Age analyzed on mITT population.
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=72 Participants • Age analyzed on mITT population.
|
57 Participants
n=77 Participants • Age analyzed on mITT population.
|
62 Participants
n=80 Participants • Age analyzed on mITT population.
|
176 Participants
n=229 Participants • Age analyzed on mITT population.
|
|
Age, Categorical
>=65 years
|
15 Participants
n=72 Participants • Age analyzed on mITT population.
|
20 Participants
n=77 Participants • Age analyzed on mITT population.
|
18 Participants
n=80 Participants • Age analyzed on mITT population.
|
53 Participants
n=229 Participants • Age analyzed on mITT population.
|
|
Sex: Female, Male
Female
|
17 Participants
n=72 Participants • Gender analyzed on mITT population
|
18 Participants
n=77 Participants • Gender analyzed on mITT population
|
20 Participants
n=80 Participants • Gender analyzed on mITT population
|
55 Participants
n=229 Participants • Gender analyzed on mITT population
|
|
Sex: Female, Male
Male
|
55 Participants
n=72 Participants • Gender analyzed on mITT population
|
59 Participants
n=77 Participants • Gender analyzed on mITT population
|
60 Participants
n=80 Participants • Gender analyzed on mITT population
|
174 Participants
n=229 Participants • Gender analyzed on mITT population
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Hungary
|
25 participants
n=98 Participants
|
20 participants
n=99 Participants
|
22 participants
n=98 Participants
|
67 participants
n=295 Participants
|
|
Region of Enrollment
Poland
|
26 participants
n=98 Participants
|
25 participants
n=99 Participants
|
23 participants
n=98 Participants
|
74 participants
n=295 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=98 Participants
|
2 participants
n=99 Participants
|
2 participants
n=98 Participants
|
5 participants
n=295 Participants
|
|
Region of Enrollment
Slovakia
|
21 participants
n=98 Participants
|
26 participants
n=99 Participants
|
23 participants
n=98 Participants
|
70 participants
n=295 Participants
|
|
Region of Enrollment
France
|
13 participants
n=98 Participants
|
14 participants
n=99 Participants
|
13 participants
n=98 Participants
|
40 participants
n=295 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=98 Participants
|
3 participants
n=99 Participants
|
4 participants
n=98 Participants
|
11 participants
n=295 Participants
|
|
Region of Enrollment
Spain
|
8 participants
n=98 Participants
|
9 participants
n=99 Participants
|
11 participants
n=98 Participants
|
28 participants
n=295 Participants
|
PRIMARY outcome
Timeframe: 84 daysComparison of the effects of BID oral administration of 2 doses of firibastat to those of BID oral administration of ramipril on the change from Baseline in LVEF on Day 84
Outcome measures
| Measure |
Group 1: Firibastat 100 mg
n=72 Participants
Subjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks.
Firibastat: 1 or 2 capsules administered orally, twice daily
|
Group 2: Firibastat 500 mg
n=77 Participants
Subjects will receive 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks.
Firibastat: 1 or 2 capsules administered orally, twice daily
|
Group 3: Ramipril 5 mg
n=80 Participants
Subjects will receive 2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks.
Ramipril: 1 or 2 capsules administered orally, twice daily
|
|---|---|---|---|
|
Left Ventricular Ejection Fraction Assessed by Cardiac Magnetic Resonance Imaging (CMRI)
|
5.6 percentage of left ventricular volumes
Standard Deviation 1.2
|
5.3 percentage of left ventricular volumes
Standard Deviation 1.1
|
5.7 percentage of left ventricular volumes
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 84 daysComparison of the effects of BID administration of firibastat and ramipril on the change from Baseline to Day 84 in left-ventricle end-diastolic volume
Outcome measures
| Measure |
Group 1: Firibastat 100 mg
n=72 Participants
Subjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks.
Firibastat: 1 or 2 capsules administered orally, twice daily
|
Group 2: Firibastat 500 mg
n=77 Participants
Subjects will receive 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks.
Firibastat: 1 or 2 capsules administered orally, twice daily
|
Group 3: Ramipril 5 mg
n=80 Participants
Subjects will receive 2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks.
Ramipril: 1 or 2 capsules administered orally, twice daily
|
|---|---|---|---|
|
Left-ventricle End-diastolic Volume Assessed by CMRI
|
14.2 mL
Standard Deviation 4.5
|
12.7 mL
Standard Deviation 4.3
|
9.4 mL
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: 84 daysComparison of the effects of BID administration of firibastat and ramipril on the change from Baseline to Day 84 in left-ventricle end-systolic volume
Outcome measures
| Measure |
Group 1: Firibastat 100 mg
n=72 Participants
Subjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks.
Firibastat: 1 or 2 capsules administered orally, twice daily
|
Group 2: Firibastat 500 mg
n=77 Participants
Subjects will receive 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks.
Firibastat: 1 or 2 capsules administered orally, twice daily
|
Group 3: Ramipril 5 mg
n=80 Participants
Subjects will receive 2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks.
Ramipril: 1 or 2 capsules administered orally, twice daily
|
|---|---|---|---|
|
Left-ventricle End-systolic Volume Assessed by CMRI
|
-0.5 mL
Standard Deviation 3.3
|
-0.4 mL
Standard Deviation 3.2
|
-3.1 mL
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 84 daysComparison of the effects of BID administration of firibastat and ramipril on major cardiac event (MACE) over 84 days
Outcome measures
| Measure |
Group 1: Firibastat 100 mg
n=98 Participants
Subjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks.
Firibastat: 1 or 2 capsules administered orally, twice daily
|
Group 2: Firibastat 500 mg
n=98 Participants
Subjects will receive 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks.
Firibastat: 1 or 2 capsules administered orally, twice daily
|
Group 3: Ramipril 5 mg
n=98 Participants
Subjects will receive 2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks.
Ramipril: 1 or 2 capsules administered orally, twice daily
|
|---|---|---|---|
|
Major Cardiac Event (MACE): Combined Clinical Endpoint of Cardiovascular Death, MI, and Cardiac Hospitalization
|
10 Event
|
8 Event
|
6 Event
|
SECONDARY outcome
Timeframe: 84 daysComparison of the effects of BID administration of firibastat and ramipril on the change from Baseline to Day 84 in N-terminal pro b-type natriuretic peptide (NT proBNP)
Outcome measures
| Measure |
Group 1: Firibastat 100 mg
n=72 Participants
Subjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks.
Firibastat: 1 or 2 capsules administered orally, twice daily
|
Group 2: Firibastat 500 mg
n=77 Participants
Subjects will receive 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks.
Firibastat: 1 or 2 capsules administered orally, twice daily
|
Group 3: Ramipril 5 mg
n=80 Participants
Subjects will receive 2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks.
Ramipril: 1 or 2 capsules administered orally, twice daily
|
|---|---|---|---|
|
N-terminal Pro B-type Natriuretic Peptide (NT proBNP)
|
-1618.7 pg/ml
Standard Deviation 1381.7
|
-1596.4 pg/ml
Standard Deviation 2279.6
|
-1735.6 pg/ml
Standard Deviation 2326.5
|
Adverse Events
Group 1: Firibastat 100 mg
Serious events: 11 serious events
Other events: 43 other events
Deaths: 2 deaths
Group 2: Firibastat 500 mg
Serious events: 18 serious events
Other events: 54 other events
Deaths: 1 deaths
Group 3: Ramipril 5 mg
Serious events: 10 serious events
Other events: 54 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group 1: Firibastat 100 mg
n=98 participants at risk
Subjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks.
Firibastat: 1 or 2 capsules administered orally, twice daily
|
Group 2: Firibastat 500 mg
n=98 participants at risk
Subjects will receive 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks.
Firibastat: 1 or 2 capsules administered orally, twice daily
|
Group 3: Ramipril 5 mg
n=98 participants at risk
Subjects will receive 2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks.
Ramipril: 1 or 2 capsules administered orally, twice daily
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
|
Cardiac disorders
Myocardial Infarction
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Cardiac disorders
Aortic valve incompetence
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
|
Cardiac disorders
Cardiac failure
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Cardiac disorders
Cardiac tamponade
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Cardiac disorders
Coronary artery disease
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Cardiac disorders
Dressler's syndrome
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Cardiac disorders
Ventricule rupture
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Endocrine disorders
Hyperplasia adrenal
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Eye disorders
Retinal Detachment
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
General disorders
Chest pain or chest discomfort (non cardiac)
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
3.1%
3/98 • Number of events 3 • Adverse events collected from the ICF signature to the end of the study.
|
|
General disorders
Death
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
General disorders
Vascular stent trombosis
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
|
Infections and infestations
COVID19
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
3.1%
3/98 • Number of events 3 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Injury, poisoning and procedural complications
Periprocedural myocadial infarction
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Nervous system disorders
Ischaemic stroke
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dypsnoea
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
Other adverse events
| Measure |
Group 1: Firibastat 100 mg
n=98 participants at risk
Subjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks.
Firibastat: 1 or 2 capsules administered orally, twice daily
|
Group 2: Firibastat 500 mg
n=98 participants at risk
Subjects will receive 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks.
Firibastat: 1 or 2 capsules administered orally, twice daily
|
Group 3: Ramipril 5 mg
n=98 participants at risk
Subjects will receive 2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks.
Ramipril: 1 or 2 capsules administered orally, twice daily
|
|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
|
Cardiac disorders
Cardiac failure
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
3.1%
3/98 • Number of events 4 • Adverse events collected from the ICF signature to the end of the study.
|
|
Cardiac disorders
Coronary artery disease
|
3.1%
3/98 • Number of events 4 • Adverse events collected from the ICF signature to the end of the study.
|
3.1%
3/98 • Number of events 3 • Adverse events collected from the ICF signature to the end of the study.
|
4.1%
4/98 • Number of events 4 • Adverse events collected from the ICF signature to the end of the study.
|
|
Cardiac disorders
Dressler's syndrome
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
3.1%
3/98 • Number of events 3 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
8.2%
8/98 • Number of events 9 • Adverse events collected from the ICF signature to the end of the study.
|
3.1%
3/98 • Number of events 3 • Adverse events collected from the ICF signature to the end of the study.
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
3.1%
3/98 • Number of events 3 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Infections and infestations
COVID-19
|
3.1%
3/98 • Number of events 3 • Adverse events collected from the ICF signature to the end of the study.
|
4.1%
4/98 • Number of events 4 • Adverse events collected from the ICF signature to the end of the study.
|
6.1%
6/98 • Number of events 6 • Adverse events collected from the ICF signature to the end of the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
|
Nervous system disorders
Dizziness
|
3.1%
3/98 • Number of events 3 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
|
Vascular disorders
Hypertension
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
4.1%
4/98 • Number of events 4 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Vascular disorders
Hypotension
|
4.1%
4/98 • Number of events 4 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
|
Vascular disorders
Orthostatic hypotension
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
General disorders
Chest disconfort
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
5.1%
5/98 • Number of events 5 • Adverse events collected from the ICF signature to the end of the study.
|
|
General disorders
Chest pain
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
4.1%
4/98 • Number of events 4 • Adverse events collected from the ICF signature to the end of the study.
|
5.1%
5/98 • Number of events 6 • Adverse events collected from the ICF signature to the end of the study.
|
|
General disorders
Peripheral swelling
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
General disorders
Pyrexia
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
|
Gastrointestinal disorders
Diarrhea
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
5.1%
5/98 • Number of events 6 • Adverse events collected from the ICF signature to the end of the study.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dypsnoea
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 3 • Adverse events collected from the ICF signature to the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
3.1%
3/98 • Number of events 3 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
3.1%
3/98 • Number of events 3 • Adverse events collected from the ICF signature to the end of the study.
|
|
Hepatobiliary disorders
Liver disorder
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
3.1%
3/98 • Number of events 4 • Adverse events collected from the ICF signature to the end of the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
1.0%
1/98 • Number of events 1 • Adverse events collected from the ICF signature to the end of the study.
|
4.1%
4/98 • Number of events 4 • Adverse events collected from the ICF signature to the end of the study.
|
|
Investigations
ECG QT prolonged
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
2.0%
2/98 • Number of events 2 • Adverse events collected from the ICF signature to the end of the study.
|
0.00%
0/98 • Adverse events collected from the ICF signature to the end of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60