Trial Outcomes & Findings for Trial of AD036 in Obstructive Sleep Apnea (NCT NCT03845023)
NCT ID: NCT03845023
Last Updated: 2023-01-17
Results Overview
Number of participants with ≥50% reduction in apnea hypopnea index (AHI). AHI is the average number of apneas and hypopneas a person experiences each hour during sleep, to register as an event an apnea or hypopnea must last at least 10 seconds or longer. To measure this, doctors divide the total number of apneic and hypopneic events by the total number of hours the person was asleep.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
140 participants
Primary outcome timeframe
10 days
Results posted on
2023-01-17
Participant Flow
Subjects were recruited from 12 clinical sites (hospitals and sleep centers). The study population consisted of male and female subjects between 25 and 65 years of age, inclusive, with OSA documented by PSG. Overall study duration was up to 8 weeks. Dosing of the study treatment was to occur approximately 30 minutes prior to bedtime. Subjects who withdrew from the study were not replaced.
Participant milestones
| Measure |
Placebo
Placebo oral capsule administered orally at bedtime
|
AD036 Dose 1
AD036 Dose 1 (Low Dose 25/5) administered orally before bedtime
|
AD036 Dose 2
75/1.5 administered orally at bedtime.
|
AD036 Dose 3
AD036 75/5 administered orally at bedtime
|
|---|---|---|---|---|
|
Placebo Run-In Period (2 Nights)
STARTED
|
36
|
36
|
34
|
34
|
|
Placebo Run-In Period (2 Nights)
COMPLETED
|
36
|
36
|
34
|
34
|
|
Placebo Run-In Period (2 Nights)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Low Dose Run-In (3 Nights)
STARTED
|
36
|
36
|
34
|
34
|
|
Low Dose Run-In (3 Nights)
COMPLETED
|
36
|
36
|
34
|
34
|
|
Low Dose Run-In (3 Nights)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period (7 Nights)
STARTED
|
36
|
36
|
34
|
34
|
|
Treatment Period (7 Nights)
COMPLETED
|
36
|
36
|
34
|
34
|
|
Treatment Period (7 Nights)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Follow-Up (14 Days)
STARTED
|
36
|
36
|
34
|
34
|
|
Follow-Up (14 Days)
COMPLETED
|
35
|
36
|
33
|
33
|
|
Follow-Up (14 Days)
NOT COMPLETED
|
1
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Placebo oral capsule administered orally at bedtime
|
AD036 Dose 1
AD036 Dose 1 (Low Dose 25/5) administered orally before bedtime
|
AD036 Dose 2
75/1.5 administered orally at bedtime.
|
AD036 Dose 3
AD036 75/5 administered orally at bedtime
|
|---|---|---|---|---|
|
Follow-Up (14 Days)
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Follow-Up (14 Days)
Adverse Event
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Trial of AD036 in Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
Placebo
n=36 Participants
Placebo oral capsule administered orally at bedtime
|
AD036 Dose 1
n=36 Participants
AD036 Dose 1 (Low Dose 25/5) administered orally before bedtime
|
AD036 Dose 2
n=34 Participants
75/1.5 administered orally at bedtime.
|
AD036 Dose 3
n=34 Participants
AD036 75/5 administered orally at bedtime
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
132 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
98 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
129 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 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
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
BMI (kg/m^2)
|
32.930 kg/m^2
n=5 Participants
|
33.445 kg/m^2
n=7 Participants
|
32.555 kg/m^2
n=5 Participants
|
33.170 kg/m^2
n=4 Participants
|
32.745 kg/m^2
n=21 Participants
|
PRIMARY outcome
Timeframe: 10 daysPopulation: All randomized subjects were included in the mITT
Number of participants with ≥50% reduction in apnea hypopnea index (AHI). AHI is the average number of apneas and hypopneas a person experiences each hour during sleep, to register as an event an apnea or hypopnea must last at least 10 seconds or longer. To measure this, doctors divide the total number of apneic and hypopneic events by the total number of hours the person was asleep.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo oral capsule administered orally at bedtime
|
AD036 Dose 1
n=36 Participants
AD036 Dose 1 (Low Dose 25/5) administered orally before bedtime
|
AD036 Dose 2
n=34 Participants
75/1.5 administered orally at bedtime.
|
AD036 Dose 3
n=34 Participants
AD036 75/5 administered orally at bedtime
|
|---|---|---|---|---|
|
Apnea Hypopnea Index (AHI)
Yes (subjects that had a 50% reduction in AHI)
|
3 Participants
|
2 Participants
|
6 Participants
|
8 Participants
|
|
Apnea Hypopnea Index (AHI)
No (subjects that did not have a 50% reduction in AHI)
|
33 Participants
|
34 Participants
|
28 Participants
|
26 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
AD036 Dose 1
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
AD036 Dose 2
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
AD036 Dose 3
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=140 participants at risk
Placebo oral capsule administered orally at bedtime
|
AD036 Dose 1
n=104 participants at risk
AD036 Dose 1 (Low Dose 25/5) administered orally before bedtime
|
AD036 Dose 2
n=34 participants at risk
75/1.5 administered orally at bedtime.
|
AD036 Dose 3
n=34 participants at risk
AD036 75/5 administered orally at bedtime
|
|---|---|---|---|---|
|
Renal and urinary disorders
Acute Kidney injury
|
0.00%
0/140 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.96%
1/104 • Number of events 1 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/34 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/34 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
Other adverse events
| Measure |
Placebo
n=140 participants at risk
Placebo oral capsule administered orally at bedtime
|
AD036 Dose 1
n=104 participants at risk
AD036 Dose 1 (Low Dose 25/5) administered orally before bedtime
|
AD036 Dose 2
n=34 participants at risk
75/1.5 administered orally at bedtime.
|
AD036 Dose 3
n=34 participants at risk
AD036 75/5 administered orally at bedtime
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
1.4%
2/140 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
5.8%
6/104 • Number of events 6 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
23.5%
8/34 • Number of events 8 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/140 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
1.9%
2/104 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
14.7%
5/34 • Number of events 5 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Gastrointestinal disorders
dyspepsia
|
1.4%
2/140 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.96%
1/104 • Number of events 1 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/34 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/140 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
2.9%
3/104 • Number of events 3 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/34 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/140 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/104 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/34 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Nervous system disorders
headache
|
2.1%
3/140 • Number of events 3 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
3.8%
4/104 • Number of events 4 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
20.6%
7/34 • Number of events 7 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/34 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Nervous system disorders
Somnolence
|
0.71%
1/140 • Number of events 1 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.96%
1/104 • Number of events 1 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Nervous system disorders
Poor Quality Sleep
|
0.00%
0/140 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/104 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/34 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Psychiatric disorders
Insomnia
|
0.71%
1/140 • Number of events 1 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/104 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
14.7%
5/34 • Number of events 5 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
8.8%
3/34 • Number of events 3 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/140 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.96%
1/104 • Number of events 1 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Psychiatric disorders
Depression
|
0.71%
1/140 • Number of events 1 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/104 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/34 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Psychiatric disorders
Middle Insomnia
|
0.00%
0/140 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
1.9%
2/104 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/34 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
General disorders
Fatigue
|
1.4%
2/140 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.96%
1/104 • Number of events 1 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Renal and urinary disorders
Urinary Hesitation
|
0.00%
0/140 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
1.9%
2/104 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
8.8%
3/34 • Number of events 3 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/140 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/104 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/34 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/140 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
1.9%
2/104 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/140 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
1.9%
2/104 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/34 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
0.00%
0/140 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/104 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/34 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/140 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/104 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
8.8%
3/34 • Number of events 3 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Investigations
Urine output decreased
|
0.00%
0/140 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/104 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/34 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/140 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/104 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
8.8%
3/34 • Number of events 3 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/34 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
|
Vascular disorders
hypertension
|
0.00%
0/140 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/104 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
0.00%
0/34 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over an 8 month period
The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs agreed that because the Study is part of a Multi-center Study, individual publication could not be made until the publication of the Multi-center study results, notification that that a Multi-center publication was not planned, or after 18 months had passed.
- Publication restrictions are in place
Restriction type: OTHER