Trial Outcomes & Findings for COVID-FIS: Pilot in COVID-19 (SARS-CoV-2) of Fisetin in Older Adults in Nursing Homes (NCT NCT04537299)
NCT ID: NCT04537299
Last Updated: 2025-08-26
Results Overview
The Ordinal Scale for Clinical Improvement was used to assess change in COVID-19 Severity. The scale has a minimum value of 0 (no clinical or virological evidence of infection) and a maximum value of 8 (death) with higher scores indicating a worse outcome.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline, Day 2, 8, 10, 14, 30, 90 and 180
Results posted on
2025-08-26
Participant Flow
Participant milestones
| Measure |
Treatment Group
Subjects received treatment drug (Fisetin)
Fisetin: \~20 mg/kg/day oral, NG or D tube course for 2 consecutive days twice (Days 0 \& 1 and Days 8 \& 9)
|
Placebo Group
Subjects received placebo
Placebo: Placebo looks exactly like the treatment drug, but it contains no active ingredient
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Treatment Group
Subjects received treatment drug (Fisetin)
Fisetin: \~20 mg/kg/day oral, NG or D tube course for 2 consecutive days twice (Days 0 \& 1 and Days 8 \& 9)
|
Placebo Group
Subjects received placebo
Placebo: Placebo looks exactly like the treatment drug, but it contains no active ingredient
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
COVID-FIS: Pilot in COVID-19 (SARS-CoV-2) of Fisetin in Older Adults in Nursing Homes
Baseline characteristics by cohort
| Measure |
Treatment Group
n=10 Participants
Subjects received treatment drug (Fisetin)
Fisetin: \~20 mg/kg/day oral, NG or D tube course for 2 consecutive days twice (Days 0 \& 1 and Days 8 \& 9)
|
Placebo Group
n=10 Participants
Subjects received placebo
Placebo: Placebo looks exactly like the treatment drug, but it contains no active ingredient
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
82.8 years
STANDARD_DEVIATION 7.36 • n=5 Participants
|
78.3 years
STANDARD_DEVIATION 8.05 • n=7 Participants
|
80.55 years
STANDARD_DEVIATION 8.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 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
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 2, 8, 10, 14, 30, 90 and 180Population: Data was not collected or analyzed for 1 subject in the treatment arm at day 8, day 10 and day 14 due to subject withdrawal. Data was not collected or analyzed for 2 subjects in the treatment arm at day 30, day 90 and day 180 due to subject withdrawal.
The Ordinal Scale for Clinical Improvement was used to assess change in COVID-19 Severity. The scale has a minimum value of 0 (no clinical or virological evidence of infection) and a maximum value of 8 (death) with higher scores indicating a worse outcome.
Outcome measures
| Measure |
Treatment Group
n=9 Participants
Subjects received treatment drug (Fisetin)
Fisetin: \~20 mg/kg/day oral, NG or D tube course for 2 consecutive days twice (Days 0 \& 1 and Days 8 \& 9)
|
Placebo Group
n=9 Participants
Subjects received placebo
Placebo: Placebo looks exactly like the treatment drug, but it contains no active ingredient
|
|---|---|---|
|
Change in COVID-19 Severity
Baseline to Day 2
|
1.88 score on a scale
Standard Deviation 0.31
|
2 score on a scale
Standard Deviation 0
|
|
Change in COVID-19 Severity
Baseline to Day 8
|
2 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
|
Change in COVID-19 Severity
Baseline to Day 10
|
2 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
|
Change in COVID-19 Severity
Baseline to Day 14
|
2 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
|
Change in COVID-19 Severity
Baseline to Day 30
|
2 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
|
Change in COVID-19 Severity
Baseline to Day 90
|
2 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
|
Change in COVID-19 Severity
Baseline to Day 180
|
2 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
Adverse Events
Treatment Group
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo Group
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Group
n=10 participants at risk
Subjects received treatment drug (Fisetin)
Fisetin: \~20 mg/kg/day oral, NG or D tube course for 2 consecutive days twice (Days 0 \& 1 and Days 8 \& 9)
|
Placebo Group
n=10 participants at risk
Subjects received placebo
Placebo: Placebo looks exactly like the treatment drug, but it contains no active ingredient
|
|---|---|---|
|
General disorders
Non-Cardiac Chest Pain (Intercostal Pain)
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Injury, poisoning and procedural complications
Fracture; Fracture Pubis Closed Initial Right
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
Other adverse events
| Measure |
Treatment Group
n=10 participants at risk
Subjects received treatment drug (Fisetin)
Fisetin: \~20 mg/kg/day oral, NG or D tube course for 2 consecutive days twice (Days 0 \& 1 and Days 8 \& 9)
|
Placebo Group
n=10 participants at risk
Subjects received placebo
Placebo: Placebo looks exactly like the treatment drug, but it contains no active ingredient
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia; Worsening Cronic Right Shoulder Pain
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Vascular disorders
Worsening Abdominal Aortic Aneurysm
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Musculoskeletal and connective tissue disorders
Acute Back Pain
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
General disorders
Vitamin B Deficiency
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
General disorders
Vitamin D Deficiency
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Vascular disorders
Brusing
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Skin and subcutaneous tissue disorders
Bullous Dermatitis
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Musculoskeletal and connective tissue disorders
Buttock Pain
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
General disorders
Chills
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Gastrointestinal disorders
Colitis
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Gastrointestinal disorders
Worsening Constipation
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Psychiatric disorders
Worsening Depression
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
General disorders
Edema Limbs
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
30.0%
3/10 • Number of events 3 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
30.0%
3/10 • Number of events 3 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Ear and labyrinth disorders
Hearing Loss, Bilateral
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Renal and urinary disorders
Hematuria
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Renal and urinary disorders
Hemoglobinuria
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
General disorders
Infusion Related Reaction
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Vascular disorders
Worsening Hypertension
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Skin and subcutaneous tissue disorders
Excoriation Buttocks
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercarbia
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Gastrointestinal disorders
Increased Appetite
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Skin and subcutaneous tissue disorders
Ingrown Toenail
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Psychiatric disorders
Parasomnia
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
General disorders
Pain
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
30.0%
3/10 • Number of events 4 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Psychiatric disorders
Decreased Mood
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Psychiatric disorders
Grief
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Renal and urinary disorders
Urethra Aches
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
10.0%
1/10 • Number of events 2 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Injury, poisoning and procedural complications
Abrasion
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Skin and subcutaneous tissue disorders
Incontinence Associated Dermatitis
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Infections and infestations
Skin Infection
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Gastrointestinal disorders
Stomach Pain
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Psychiatric disorders
Suicidal Ideation
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Infections and infestations
Upper Respiratory Infection
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Infections and infestations
Urinary Tract Infection
|
30.0%
3/10 • Number of events 3 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Renal and urinary disorders
Urinary Urgency
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Cardiac disorders
Ventricular Arrhythmia
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
|
Investigations
Weight Gain
|
0.00%
0/10 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place