Trial Outcomes & Findings for Jetstream in Treatment of Occlusive Atherosclerotic Lesions in the SFA and/or PPA (NCT NCT03455855)
NCT ID: NCT03455855
Last Updated: 2024-10-29
Results Overview
Acute reduction of percent diameter stenosis (%DS) post atherectomy but prior to any adjunctive therapy, when compared to its baseline diameter stenosis (absolute mean percentage).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
Index Procedure (Core-lab will analysis the procedural angiograms to assess the acute reduction of percent diameter stenosis (%DS))
Results posted on
2024-10-29
Participant Flow
Participants were recruited based on physician referral at 6 sites between Feb 2018 and Jan 2024. The first participant was enrolled on 5 Mar 2018 and the last participant was enrolled on 10 Jan 2023.
Approximately 80 subjects (including 20 roll-in subjects) in 10 sites planned to be enrolled. The sample of primary cohort is 60. The sample of roll in cohort depends on the site number. 2 roll-in subjects per site is required. Actually 6 site participated in this study, totally there are 72 subjects in all.
Participant milestones
| Measure |
Primary Cohort
The overall sample size is consist of the primary cohort and roll-in subjects. A sample size of 60 subjects to be enrolled in the primary cohort at baseline.
|
Roll in Cohort
The overall sample size is consist of the primary cohort and roll-in subjects. With additional 2 roll-in subjects per site and 6 sites are eligible for enrollment.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
12
|
|
Overall Study
Primary Endpoint(30days)
|
60
|
12
|
|
Overall Study
COMPLETED
|
56
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Primary Cohort
The overall sample size is consist of the primary cohort and roll-in subjects. A sample size of 60 subjects to be enrolled in the primary cohort at baseline.
|
Roll in Cohort
The overall sample size is consist of the primary cohort and roll-in subjects. With additional 2 roll-in subjects per site and 6 sites are eligible for enrollment.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
Baseline Characteristics
Jetstream in Treatment of Occlusive Atherosclerotic Lesions in the SFA and/or PPA
Baseline characteristics by cohort
| Measure |
Primary Cohort
n=60 Participants
The overall sample size is consist of the primary cohort and roll-in subjects. A sample size of 60 subjects to be enrolled in the primary cohort at baseline.
|
Roll in Cohort
n=12 Participants
The overall sample size is consist of the primary cohort and roll-in subjects. With additional 2 roll-in subjects per site and 6 sites are eligible for enrollment.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 years
n=5 Participants
|
64.9 years
n=7 Participants
|
67.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
60 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Index Procedure (Core-lab will analysis the procedural angiograms to assess the acute reduction of percent diameter stenosis (%DS))Population: 57/60 subjects from primary cohort and 11/12 subjects from roll in cohort received primary effectiveness endpoint analysis from core lab.
Acute reduction of percent diameter stenosis (%DS) post atherectomy but prior to any adjunctive therapy, when compared to its baseline diameter stenosis (absolute mean percentage).
Outcome measures
| Measure |
Primary Cohort
n=57 Participants
The overall sample size is consist of the primary cohort and roll-in subjects. A sample size of 60 subjects to be enrolled in the primary cohort at baseline.
|
Roll in Cohort
n=11 Participants
The overall sample size is consist of the primary cohort and roll-in subjects. With additional 2 roll-in subjects per site and 6 sites are eligible for enrollment.
|
Overall Cohort
n=68 Participants
The overall sample size is consist of the primary cohort and roll-in subjects.
|
|---|---|---|---|
|
The Primary Effectiveness Endpoint-Acute Reduction of Percent Diameter Stenosis
|
39.3 percentage of DS(diameter stenosis)
Standard Deviation 16.1
|
42.8 percentage of DS(diameter stenosis)
Standard Deviation 11.1
|
39.9 percentage of DS(diameter stenosis)
Standard Deviation 15.4
|
PRIMARY outcome
Timeframe: 30daysdefined as all-cause death, target limb unplanned major amputation and/or target lesion revascularization (TLR), within 30 days post index procedure.
Outcome measures
| Measure |
Primary Cohort
n=60 Participants
The overall sample size is consist of the primary cohort and roll-in subjects. A sample size of 60 subjects to be enrolled in the primary cohort at baseline.
|
Roll in Cohort
n=12 Participants
The overall sample size is consist of the primary cohort and roll-in subjects. With additional 2 roll-in subjects per site and 6 sites are eligible for enrollment.
|
Overall Cohort
n=72 Participants
The overall sample size is consist of the primary cohort and roll-in subjects.
|
|---|---|---|---|
|
The Primary Safety Endpoint-The Rate of Major Adverse Event (MAE) at 30 Days Follow up
|
60 Participants
|
11 Participants
|
71 Participants
|
Adverse Events
Primary Cohort
Serious events: 21 serious events
Other events: 45 other events
Deaths: 0 deaths
Roll in Cohort
Serious events: 8 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Primary Cohort
n=60 participants at risk
The overall sample size is consist of the primary cohort and roll-in subjects. A sample size of 60 subjects to be enrolled in the primary cohort at baseline.
|
Roll in Cohort
n=12 participants at risk
The overall sample size is consist of the primary cohort and roll-in subjects. With additional 2 roll-in subjects per site and 6 sites are eligible for enrollment.
|
|---|---|---|
|
Vascular disorders
Peripheral arterial occlusive disease
|
18.3%
11/60 • Number of events 12 • 1 year
MedDRA
|
25.0%
3/12 • Number of events 3 • 1 year
MedDRA
|
|
Vascular disorders
Peripheral embolism
|
5.0%
3/60 • Number of events 3 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 1 • 1 year
MedDRA
|
|
Vascular disorders
Peripheral artery occlusion
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/60 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 1 • 1 year
MedDRA
|
|
Vascular disorders
Peripheral artery thrombosis
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Vascular disorders
Vascular wall hypertrophy
|
0.00%
0/60 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 1 • 1 year
MedDRA
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
8.3%
5/60 • Number of events 5 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 1 • 1 year
MedDRA
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
3.3%
2/60 • Number of events 2 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/60 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 1 • 1 year
MedDRA
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/60 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 1 • 1 year
MedDRA
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
3.3%
2/60 • Number of events 2 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.00%
0/60 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 1 • 1 year
MedDRA
|
|
General disorders
Contrast media deposition
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/60 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 1 • 1 year
MedDRA
|
Other adverse events
| Measure |
Primary Cohort
n=60 participants at risk
The overall sample size is consist of the primary cohort and roll-in subjects. A sample size of 60 subjects to be enrolled in the primary cohort at baseline.
|
Roll in Cohort
n=12 participants at risk
The overall sample size is consist of the primary cohort and roll-in subjects. With additional 2 roll-in subjects per site and 6 sites are eligible for enrollment.
|
|---|---|---|
|
Vascular disorders
Peripheral artery stenosis
|
35.0%
21/60 • Number of events 21 • 1 year
MedDRA
|
33.3%
4/12 • Number of events 4 • 1 year
MedDRA
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
10.0%
6/60 • Number of events 6 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Vascular disorders
Hypertension
|
6.7%
4/60 • Number of events 4 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Vascular disorders
Peripheral artery occlusion
|
3.3%
2/60 • Number of events 2 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 1 • 1 year
MedDRA
|
|
Vascular disorders
Peripheral artery dissection
|
3.3%
2/60 • Number of events 2 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Vascular disorders
Hypotension
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Vascular disorders
Intermittent claudication
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Vascular disorders
Phlebitis
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Vascular disorders
Vessel perforation
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
21.7%
13/60 • Number of events 13 • 1 year
MedDRA
|
66.7%
8/12 • Number of events 9 • 1 year
MedDRA
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/60 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 1 • 1 year
MedDRA
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/60 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 1 • 1 year
MedDRA
|
|
Infections and infestations
Conjunctivitis
|
5.0%
3/60 • Number of events 3 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
3/60 • Number of events 3 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Infections and infestations
Bronchitis
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 1 • 1 year
MedDRA
|
|
Infections and infestations
Periodontitis
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 1 • 1 year
MedDRA
|
|
Infections and infestations
Pharyngitis
|
3.3%
2/60 • Number of events 2 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Infections and infestations
Pneumonia
|
1.7%
1/60 • Number of events 2 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Infections and infestations
Carbuncle
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Infections and infestations
Fungal skin infection
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Infections and infestations
Herpes zoster
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Infections and infestations
Lung infection
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Infections and infestations
Skin infection
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Infections and infestations
Soft tissue infection
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
3/60 • Number of events 4 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 2 • 1 year
MedDRA
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
3/60 • Number of events 3 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
3.3%
2/60 • Number of events 2 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Gastrointestinal disorders
Constipation
|
5.0%
3/60 • Number of events 3 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 1 • 1 year
MedDRA
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
2/60 • Number of events 2 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Gastrointestinal disorders
Gastric polyps
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Gastrointestinal disorders
Gastritis erosive
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Gastrointestinal disorders
Large intestine polyp
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
General disorders
Pyrexia
|
5.0%
3/60 • Number of events 3 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
General disorders
Chest pain
|
3.3%
2/60 • Number of events 2 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
General disorders
Vascular stent restenosis
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Cardiac disorders
Cardiac failure
|
1.7%
1/60 • Number of events 2 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Cardiac disorders
Cardiac disorder
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/60 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 1 • 1 year
MedDRA
|
|
Cardiac disorders
Coronary artery insufficiency
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Nervous system disorders
Hypoaesthesia
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 1 • 1 year
MedDRA
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Nervous system disorders
Headache
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Nervous system disorders
Neuropathy peripheral
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Investigations
Blood pressure increased
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 1 • 1 year
MedDRA
|
|
Investigations
Bilirubin conjugated increased
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
3.3%
2/60 • Number of events 2 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Renal and urinary disorders
Dysuria
|
3.3%
2/60 • Number of events 2 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Ear and labyrinth disorders
Tinnitus
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/60 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 1 • 1 year
MedDRA
|
|
Eye disorders
Diabetic retinopathy
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Eye disorders
Vision blurred
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/60 • 1 year
MedDRA
|
8.3%
1/12 • Number of events 1 • 1 year
MedDRA
|
|
Immune system disorders
Hypersensitivity
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Psychiatric disorders
Insomnia
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.7%
1/60 • Number of events 1 • 1 year
MedDRA
|
0.00%
0/12 • 1 year
MedDRA
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place