Trial Outcomes & Findings for A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder. (NCT NCT01288079)
NCT ID: NCT01288079
Last Updated: 2012-11-20
Results Overview
A 10-item scale for the evaluation of depressive symptoms. Each Montgomery Asberg Depression Rating Scale (MADRS) item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
145 participants
Primary outcome timeframe
Randomization (Week 8) to end of treatment (Week 16)
Results posted on
2012-11-20
Participant Flow
This multicenter study was conducted in Europe, Asia, and North America between 4 February 2011 and 26 April 2012.
21-day screening/washout and 8-week prospective open-label SSRI(selective serotonin reuptake inhibitors)/SNRI(selective serotonin and norepinephrine reuptake inhibitors) periods to identify population of inadequate responders(\<50% reduction in Hamilton Rating Scale for Depression total score of ≥16 and a Clinical Global Impression-Severity ≥4).
Participant milestones
| Measure |
1 mg BID TC-5214
|
4 mg BID TC-5214
|
60 mg QD Duloxetine
|
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
37
|
36
|
37
|
35
|
|
Overall Study
COMPLETED
|
17
|
9
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
20
|
27
|
19
|
17
|
Reasons for withdrawal
| Measure |
1 mg BID TC-5214
|
4 mg BID TC-5214
|
60 mg QD Duloxetine
|
Placebo
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
1
|
2
|
3
|
|
Overall Study
Severe Non-Compliance to Protocol
|
1
|
3
|
1
|
3
|
|
Overall Study
Condition under Investigation Worsened
|
0
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
0
|
2
|
|
Overall Study
Study-Specific Withdrawal Criteria
|
1
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
0
|
|
Overall Study
Other or Study Termination
|
11
|
15
|
14
|
8
|
Baseline Characteristics
A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.
Baseline characteristics by cohort
| Measure |
1 mg BID TC-5214
n=37 Participants
|
4 mg BID TC-5214
n=36 Participants
|
60 mg QD Duloxetine
n=37 Participants
|
Placebo
n=35 Participants
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
44.5 years
STANDARD_DEVIATION 13.03 • n=5 Participants
|
40.3 years
STANDARD_DEVIATION 12.50 • n=7 Participants
|
41.8 years
STANDARD_DEVIATION 12.70 • n=5 Participants
|
40.1 years
STANDARD_DEVIATION 10.49 • n=4 Participants
|
41.7 years
STANDARD_DEVIATION 12.24 • n=21 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
23 participants
n=5 Participants
|
20 participants
n=7 Participants
|
23 participants
n=5 Participants
|
20 participants
n=4 Participants
|
86 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
14 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
40 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
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/Ethnicity, Customized
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/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Hamilton Rating Scale for Depression-17 items (HAMD-17) total score at randomization
|
20.914 Scores on a scale
STANDARD_DEVIATION 3.425 • n=5 Participants
|
21.371 Scores on a scale
STANDARD_DEVIATION 3.606 • n=7 Participants
|
21.857 Scores on a scale
STANDARD_DEVIATION 3.499 • n=5 Participants
|
21.344 Scores on a scale
STANDARD_DEVIATION 4.100 • n=4 Participants
|
21.372 Scores on a scale
STANDARD_DEVIATION 3.632 • n=21 Participants
|
|
Montgomery-Asberg Depression Rating Scale (MADRS) total score at randomization
|
27.228 Scores on a scale
STANDARD_DEVIATION 5.202 • n=5 Participants
|
26.857 Scores on a scale
STANDARD_DEVIATION 5.542 • n=7 Participants
|
28.600 Scores on a scale
STANDARD_DEVIATION 6.796 • n=5 Participants
|
27.625 Scores on a scale
STANDARD_DEVIATION 5.320 • n=4 Participants
|
27.577 Scores on a scale
STANDARD_DEVIATION 5.734 • n=21 Participants
|
PRIMARY outcome
Timeframe: Randomization (Week 8) to end of treatment (Week 16)Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214, duloxetine or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
A 10-item scale for the evaluation of depressive symptoms. Each Montgomery Asberg Depression Rating Scale (MADRS) item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Outcome measures
| Measure |
1 mg BID TC-5214
n=35 Participants
|
4 mg BID TC-5214
n=35 Participants
|
60 mg QD Duloxetine
n=35 Participants
|
Placebo
n=32 Participants
|
|---|---|---|---|---|
|
Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment
|
-9.1 units on a scale
Standard Error 2.15
|
-11.2 units on a scale
Standard Error 2.56
|
-11.4 units on a scale
Standard Error 2.14
|
-7.6 units on a scale
Standard Error 2.19
|
Adverse Events
1 mg BID TC-5214
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
4 mg BID TC-5214
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
60 mg QD Duloxetine
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 mg BID TC-5214
n=37 participants at risk
|
4 mg BID TC-5214
n=35 participants at risk
|
60 mg QD Duloxetine
n=37 participants at risk
|
Placebo
n=35 participants at risk
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
Subcutaneous Abscess
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/37
|
0.00%
0/35
|
Other adverse events
| Measure |
1 mg BID TC-5214
n=37 participants at risk
|
4 mg BID TC-5214
n=35 participants at risk
|
60 mg QD Duloxetine
n=37 participants at risk
|
Placebo
n=35 participants at risk
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia Megaloblastic
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Blood and lymphatic system disorders
Eosinophilia
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/37
|
0.00%
0/35
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Eye disorders
Vision Blurred
|
0.00%
0/37
|
5.7%
2/35 • Number of events 2
|
0.00%
0/37
|
0.00%
0/35
|
|
Eye disorders
Eye Pain
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Eye disorders
Visual Impairment
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 2
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/37
|
25.7%
9/35 • Number of events 9
|
5.4%
2/37 • Number of events 2
|
5.7%
2/35 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
10.8%
4/37 • Number of events 4
|
8.6%
3/35 • Number of events 3
|
18.9%
7/37 • Number of events 9
|
5.7%
2/35 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
1/37 • Number of events 1
|
8.6%
3/35 • Number of events 3
|
2.7%
1/37 • Number of events 1
|
8.6%
3/35 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.4%
2/37 • Number of events 2
|
5.7%
2/35 • Number of events 2
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/37
|
5.7%
2/35 • Number of events 2
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/37
|
2.9%
1/35 • Number of events 2
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
2.9%
1/35 • Number of events 4
|
|
Gastrointestinal disorders
Flatulence
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Gastrointestinal disorders
Toothache
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/37
|
0.00%
0/35
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
General disorders
Asthenia
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
General disorders
Drug Withdrawal Syndrome
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
General disorders
Fatigue
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
General disorders
Feeling Abnormal
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
General disorders
Feeling Cold
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
General disorders
Pyrexia
|
2.7%
1/37 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
General disorders
Thirst
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/37
|
0.00%
0/35
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Infections and infestations
Influenza
|
2.7%
1/37 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
5.4%
2/37 • Number of events 2
|
11.4%
4/35 • Number of events 4
|
|
Infections and infestations
Nasopharyngitis
|
8.1%
3/37 • Number of events 3
|
5.7%
2/35 • Number of events 2
|
0.00%
0/37
|
8.6%
3/35 • Number of events 3
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/37
|
5.7%
2/35 • Number of events 3
|
2.7%
1/37 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Infections and infestations
Hordeolum
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/37
|
0.00%
0/35
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Infections and infestations
Urethritis
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
Procedural Dizziness
|
2.7%
1/37 • Number of events 4
|
0.00%
0/35
|
5.4%
2/37 • Number of events 5
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
Fall
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/37
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
Blood Pressure Increased
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
5.7%
2/35 • Number of events 2
|
|
Injury, poisoning and procedural complications
Heart Rate Increased
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
Weight Decreased
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Injury, poisoning and procedural complications
Weight Increased
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/37
|
8.6%
3/35 • Number of events 3
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/37
|
5.7%
2/35 • Number of events 2
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Metabolism and nutrition disorders
Folate Deficiency
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
8.1%
3/37 • Number of events 3
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/37
|
0.00%
0/35
|
5.4%
2/37 • Number of events 2
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
1/37 • Number of events 1
|
2.9%
1/35 • Number of events 2
|
0.00%
0/37
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/37
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Nervous system disorders
Dizziness
|
16.2%
6/37 • Number of events 6
|
11.4%
4/35 • Number of events 4
|
13.5%
5/37 • Number of events 8
|
17.1%
6/35 • Number of events 8
|
|
Nervous system disorders
Headache
|
10.8%
4/37 • Number of events 5
|
17.1%
6/35 • Number of events 6
|
8.1%
3/37 • Number of events 8
|
14.3%
5/35 • Number of events 8
|
|
Nervous system disorders
Somnolence
|
5.4%
2/37 • Number of events 2
|
2.9%
1/35 • Number of events 1
|
10.8%
4/37 • Number of events 5
|
0.00%
0/35
|
|
Nervous system disorders
Dizziness Postural
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
8.6%
3/35 • Number of events 8
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/37
|
0.00%
0/35
|
5.4%
2/37 • Number of events 2
|
2.9%
1/35 • Number of events 3
|
|
Nervous system disorders
Paraesthesia
|
5.4%
2/37 • Number of events 2
|
0.00%
0/35
|
0.00%
0/37
|
0.00%
0/35
|
|
Nervous system disorders
Disturbance In Attention
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/37
|
0.00%
0/35
|
|
Nervous system disorders
Formication
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Nervous system disorders
Head Discomfort
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/37
|
2.9%
1/35 • Number of events 2
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Nervous system disorders
Memory Impairment
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/37
|
0.00%
0/35
|
|
Nervous system disorders
Stupor
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Nervous system disorders
Tremor
|
2.7%
1/37 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
2.7%
1/37 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/37
|
8.6%
3/35 • Number of events 3
|
10.8%
4/37 • Number of events 4
|
5.7%
2/35 • Number of events 2
|
|
Psychiatric disorders
Agitation
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
2.7%
1/37 • Number of events 1
|
5.7%
2/35 • Number of events 2
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
5.7%
2/35 • Number of events 2
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/37
|
5.7%
2/35 • Number of events 2
|
|
Psychiatric disorders
Abnormal Dreams
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/37
|
0.00%
0/35
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Psychiatric disorders
Dissociation
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Psychiatric disorders
Hypervigilance
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Psychiatric disorders
Intentional Self-Injury
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/37
|
0.00%
0/35
|
|
Psychiatric disorders
Libido Decreased
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Psychiatric disorders
Mood Swings
|
0.00%
0/37
|
0.00%
0/35
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Psychiatric disorders
Sleep Disorder
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/37
|
0.00%
0/35
|
|
Psychiatric disorders
Tension
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Renal and urinary disorders
Nocturia
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/37
|
0.00%
0/35
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Reproductive system and breast disorders
Uterine Polyp
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.4%
2/37 • Number of events 2
|
2.9%
1/35 • Number of events 1
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/37
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Vascular disorders
Hypertension
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
0.00%
0/37
|
0.00%
0/35
|
|
Vascular disorders
Orthostatic Hypotension
|
2.7%
1/37 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Vascular disorders
Varicose Vein
|
0.00%
0/37
|
0.00%
0/35
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60