Trial Outcomes & Findings for Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder (NCT NCT00824291)
NCT ID: NCT00824291
Last Updated: 2011-03-10
Results Overview
HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
437 participants
Primary outcome timeframe
At Baseline and Week 12.
Results posted on
2011-03-10
Participant Flow
A total of 752 potential participants were screened for this study. 437 participants were randomized to treatment groups while 315 participants were not randomized (288: did not meet the study criteria; 27 were not randomized for other reasons). Of the 437 randomized participants, 10 participants did not receive the study treatment.
Participant milestones
| Measure |
DVS SR 50 mg
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
|
Placebo
Participants were administered an oral dose of placebo once daily with or without food.
|
|---|---|---|
|
Overall Study
STARTED
|
285
|
142
|
|
Overall Study
COMPLETED
|
231
|
107
|
|
Overall Study
NOT COMPLETED
|
54
|
35
|
Reasons for withdrawal
| Measure |
DVS SR 50 mg
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
|
Placebo
Participants were administered an oral dose of placebo once daily with or without food.
|
|---|---|---|
|
Overall Study
Adverse Event
|
15
|
6
|
|
Overall Study
Discontinuation of Study by Sponsor
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
11
|
9
|
|
Overall Study
Non-compliance
|
1
|
1
|
|
Overall Study
Protocol Violation
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
14
|
8
|
|
Overall Study
Lack of Efficacy
|
7
|
8
|
|
Overall Study
Participant on prohibited medication
|
1
|
0
|
Baseline Characteristics
Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
DVS SR 50 mg
n=285 Participants
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
|
Placebo
n=142 Participants
Participants were administered an oral dose of placebo once daily with or without food.
|
Total
n=427 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
43.16 years
STANDARD_DEVIATION 11.72 • n=5 Participants
|
41.57 years
STANDARD_DEVIATION 12.64 • n=7 Participants
|
42.63 years
STANDARD_DEVIATION 12.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
188 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
281 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Baseline and Week 12.Population: Intent-to-treat (ITT) analysis set, Last Observation Carried Forward (LOCF)
HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline.
Outcome measures
| Measure |
DVS SR 50 mg
n=285 Participants
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
|
Placebo
n=142 Participants
Participants were administered an oral dose of placebo once daily with or without food.
|
|---|---|---|
|
Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12
|
-12.61 Scores on a scale
Standard Error 0.45
|
-10.50 Scores on a scale
Standard Error 0.60
|
SECONDARY outcome
Timeframe: At Baseline and Week 12.Population: ITT, LOCF
Participant rated scale was used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Individual item scores range from 0 to 10.
Outcome measures
| Measure |
DVS SR 50 mg
n=285 Participants
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
|
Placebo
n=142 Participants
Participants were administered an oral dose of placebo once daily with or without food.
|
|---|---|---|
|
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12
|
-9.41 Scores on a scale
Standard Error 0.48
|
-8.08 Scores on a scale
Standard Error 0.63
|
SECONDARY outcome
Timeframe: At Baseline and Week 12.Population: ITT, LOCF
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Change = score at observation minus score at baseline.
Outcome measures
| Measure |
DVS SR 50 mg
n=285 Participants
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
|
Placebo
n=142 Participants
Participants were administered an oral dose of placebo once daily with or without food.
|
|---|---|---|
|
Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12
1 (Very Much Improved)
|
103 Scores on a scale
0.07
|
31 Scores on a scale
0.10
|
|
Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12
2 (Much Improved)
|
84 Scores on a scale
|
44 Scores on a scale
|
|
Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12
3 (Minimally Improved)
|
53 Scores on a scale
|
31 Scores on a scale
|
|
Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12
4 (No Change)
|
34 Scores on a scale
|
30 Scores on a scale
|
|
Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12
5 (Minimally Worse)
|
10 Scores on a scale
|
5 Scores on a scale
|
|
Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12
6 (Much Worse)
|
0 Scores on a scale
|
1 Scores on a scale
|
|
Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12
7 (Very Much Worse)
|
1 Scores on a scale
|
0 Scores on a scale
|
SECONDARY outcome
Timeframe: At Baseline and Week 12.Population: ITT, LOCF
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.
Outcome measures
| Measure |
DVS SR 50 mg
n=285 Participants
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
|
Placebo
n=142 Participants
Participants were administered an oral dose of placebo once daily with or without food.
|
|---|---|---|
|
Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12
1 (Very Much Improved)
|
69 Scores on a scale
0.08
|
23 Scores on a scale
0.11
|
|
Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12
2 (Much Improved)
|
68 Scores on a scale
|
30 Scores on a scale
|
|
Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12
3 (Minimally Improved)
|
77 Scores on a scale
|
31 Scores on a scale
|
|
Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12
4 (No Change)
|
56 Scores on a scale
|
43 Scores on a scale
|
|
Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12
5 (Minimally Worse)
|
14 Scores on a scale
|
15 Scores on a scale
|
|
Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12
6 (Much Worse)
|
1 Scores on a scale
|
0 Scores on a scale
|
|
Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12
7 (Very Much Worse)
|
0 Scores on a scale
|
0 Scores on a scale
|
SECONDARY outcome
Timeframe: At Baseline and Week 12.Population: ITT, LOCF
The Work and Activities Item of the HAM-D17 is item 7 of HAM-D17. Scoring range from 0 to 4.
Outcome measures
| Measure |
DVS SR 50 mg
n=285 Participants
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
|
Placebo
n=142 Participants
Participants were administered an oral dose of placebo once daily with or without food.
|
|---|---|---|
|
Change From Baseline on Work and Activities Item of HAM-D17 at Week 12
|
-1.68 Scores on a scale
Standard Error 0.07
|
-1.45 Scores on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: At Baseline and Week 12.Population: ITT, LOCF
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Outcome measures
| Measure |
DVS SR 50 mg
n=265 Participants
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
|
Placebo
n=125 Participants
Participants were administered an oral dose of placebo once daily with or without food.
|
|---|---|---|
|
Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12
|
-18.44 Scores on a scale
Standard Error 0.69
|
-16.18 Scores on a scale
Standard Error 0.94
|
SECONDARY outcome
Timeframe: At Baseline and Week 12.Population: ITT, LOCF
WATS: a self-administered, 3-question rating scale assesses worry, anxiety, and tension. Each item was a visual analog scale on which the participant circles a number from 0 to 10. Higher scores indicated worse function. WATS total score was the sum of the 3 items. If 1 item was missing, the total score would be missing.
Outcome measures
| Measure |
DVS SR 50 mg
n=285 Participants
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
|
Placebo
n=142 Participants
Participants were administered an oral dose of placebo once daily with or without food.
|
|---|---|---|
|
Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12
|
-13.39 Scores on a scale
Standard Error 0.79
|
-10.95 Scores on a scale
Standard Error 1.04
|
SECONDARY outcome
Timeframe: At Baseline and Week 12.Population: ITT, LOCF
Stress and Social Support Scales: self-administered rating scale where item 1 is the stress vulnerability scale measuring how much the subject was set back by stressful events on an 11-point scale ranging from 0 (not at all) to 10 (extremely) and item 2 is an 11-point scale ranging from 0 to 100 percent of the amount of support the subject received from relatives and friends.
Outcome measures
| Measure |
DVS SR 50 mg
n=285 Participants
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
|
Placebo
n=142 Participants
Participants were administered an oral dose of placebo once daily with or without food.
|
|---|---|---|
|
Change From Baseline on Stress and Social Support Scales at Week 12
|
-2.53 Scores on a scale
Standard Error 0.18
|
-2.14 Scores on a scale
Standard Error 0.23
|
Adverse Events
DVS SR 50 mg
Serious events: 2 serious events
Other events: 213 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DVS SR 50 mg
n=285 participants at risk
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
|
Placebo
n=142 participants at risk
Participants were administered an oral dose of placebo once daily with or without food.
|
|---|---|---|
|
Psychiatric disorders
Major depression
|
0.35%
1/285
|
0.00%
0/142
|
|
Nervous system disorders
Amnesia
|
0.35%
1/285
|
0.00%
0/142
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/285
|
0.70%
1/142
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/285
|
0.70%
1/142
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/285
|
0.70%
1/142
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/285
|
0.70%
1/142
|
Other adverse events
| Measure |
DVS SR 50 mg
n=285 participants at risk
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
|
Placebo
n=142 participants at risk
Participants were administered an oral dose of placebo once daily with or without food.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.35%
1/285
|
0.70%
1/142
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.35%
1/285
|
0.00%
0/142
|
|
Cardiac disorders
Palpitations
|
1.8%
5/285
|
0.70%
1/142
|
|
Cardiac disorders
Sinus bradycardia
|
0.35%
1/285
|
0.00%
0/142
|
|
Cardiac disorders
Tachycardia
|
0.35%
1/285
|
0.70%
1/142
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/285
|
0.70%
1/142
|
|
Ear and labyrinth disorders
Tinnitus
|
1.1%
3/285
|
0.70%
1/142
|
|
Ear and labyrinth disorders
Vertigo
|
0.35%
1/285
|
0.00%
0/142
|
|
Endocrine disorders
Hypothyroidism
|
0.35%
1/285
|
0.00%
0/142
|
|
Eye disorders
Blepharospasm
|
0.35%
1/285
|
0.00%
0/142
|
|
Eye disorders
Contact lens intolerance
|
0.35%
1/285
|
0.00%
0/142
|
|
Eye disorders
Eyelid ptosis
|
0.35%
1/285
|
0.00%
0/142
|
|
Eye disorders
Mydriasis
|
0.35%
1/285
|
0.00%
0/142
|
|
Eye disorders
Photopsia
|
0.00%
0/285
|
0.70%
1/142
|
|
Eye disorders
Vision blurred
|
0.35%
1/285
|
1.4%
2/142
|
|
Eye disorders
Visual impairment
|
0.35%
1/285
|
0.00%
0/142
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.70%
2/285
|
0.70%
1/142
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/285
|
0.70%
1/142
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
4/285
|
0.70%
1/142
|
|
Gastrointestinal disorders
Constipation
|
6.3%
18/285
|
7.7%
11/142
|
|
Gastrointestinal disorders
Diarrhea
|
6.3%
18/285
|
7.0%
10/142
|
|
Gastrointestinal disorders
Dry mouth
|
16.8%
48/285
|
6.3%
9/142
|
|
Gastrointestinal disorders
Dyspepsia
|
1.4%
4/285
|
1.4%
2/142
|
|
Gastrointestinal disorders
Eructation
|
0.70%
2/285
|
0.70%
1/142
|
|
Gastrointestinal disorders
Flatulence
|
1.1%
3/285
|
4.2%
6/142
|
|
Gastrointestinal disorders
Food poisoning
|
0.35%
1/285
|
0.70%
1/142
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.35%
1/285
|
0.00%
0/142
|
|
Gastrointestinal disorders
Nausea
|
19.6%
56/285
|
5.6%
8/142
|
|
Gastrointestinal disorders
Toothache
|
0.35%
1/285
|
0.70%
1/142
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
6/285
|
2.8%
4/142
|
|
General disorders
Asthenia
|
1.1%
3/285
|
0.70%
1/142
|
|
General disorders
Facial pain
|
0.35%
1/285
|
0.00%
0/142
|
|
General disorders
Fatigue
|
5.6%
16/285
|
3.5%
5/142
|
|
General disorders
Feeling abnormal
|
0.00%
0/285
|
0.70%
1/142
|
|
General disorders
Feeling drunk
|
0.00%
0/285
|
0.70%
1/142
|
|
General disorders
Feeling jittery
|
1.8%
5/285
|
0.00%
0/142
|
|
General disorders
Influenza like illness
|
0.35%
1/285
|
0.70%
1/142
|
|
General disorders
Irritability
|
1.1%
3/285
|
2.8%
4/142
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/285
|
0.70%
1/142
|
|
General disorders
Edema peripheral
|
0.70%
2/285
|
0.70%
1/142
|
|
General disorders
Pyrexia
|
0.70%
2/285
|
0.00%
0/142
|
|
General disorders
Thirst
|
0.35%
1/285
|
0.00%
0/142
|
|
Immune system disorders
Seasonal allergy
|
0.35%
1/285
|
0.70%
1/142
|
|
Infections and infestations
Bronchitis
|
0.70%
2/285
|
1.4%
2/142
|
|
Infections and infestations
Cystitis
|
0.35%
1/285
|
0.70%
1/142
|
|
Infections and infestations
Ear infection
|
0.70%
2/285
|
0.00%
0/142
|
|
Infections and infestations
Fungal infection
|
0.35%
1/285
|
0.00%
0/142
|
|
Infections and infestations
Gastroenteritis
|
0.35%
1/285
|
0.70%
1/142
|
|
Infections and infestations
Gastroenteritis viral
|
0.70%
2/285
|
0.00%
0/142
|
|
Infections and infestations
Giardiasis
|
0.35%
1/285
|
0.00%
0/142
|
|
Infections and infestations
Herpes simplex
|
0.35%
1/285
|
0.00%
0/142
|
|
Infections and infestations
Influenza
|
1.1%
3/285
|
1.4%
2/142
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
5/285
|
2.1%
3/142
|
|
Infections and infestations
Otitis media
|
0.35%
1/285
|
0.00%
0/142
|
|
Infections and infestations
Pharyngitis
|
0.35%
1/285
|
0.70%
1/142
|
|
Infections and infestations
Pharyngitis bacterial
|
0.35%
1/285
|
0.00%
0/142
|
|
Infections and infestations
Pneumonia
|
0.35%
1/285
|
0.00%
0/142
|
|
Infections and infestations
Pneumonia primary atypical
|
0.35%
1/285
|
0.00%
0/142
|
|
Infections and infestations
Tooth abscess
|
0.35%
1/285
|
0.70%
1/142
|
|
Infections and infestations
Tooth infection
|
0.00%
0/285
|
0.70%
1/142
|
|
Infections and infestations
Upper respiratory tract infection
|
2.5%
7/285
|
1.4%
2/142
|
|
Infections and infestations
Urinary tract infection
|
0.70%
2/285
|
1.4%
2/142
|
|
General disorders
Vaginal infection
|
0.35%
1/285
|
0.00%
0/142
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.35%
1/285
|
0.00%
0/142
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
2.5%
7/285
|
2.8%
4/142
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.35%
1/285
|
0.00%
0/142
|
|
Injury, poisoning and procedural complications
Contusion
|
0.70%
2/285
|
0.00%
0/142
|
|
Injury, poisoning and procedural complications
Fall
|
0.35%
1/285
|
0.00%
0/142
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.70%
2/285
|
0.00%
0/142
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.35%
1/285
|
0.00%
0/142
|
|
Injury, poisoning and procedural complications
Injury
|
0.35%
1/285
|
0.00%
0/142
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.35%
1/285
|
0.00%
0/142
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/285
|
0.70%
1/142
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.35%
1/285
|
0.00%
0/142
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.35%
1/285
|
0.00%
0/142
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/285
|
1.4%
2/142
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.35%
1/285
|
0.70%
1/142
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/285
|
0.70%
1/142
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.35%
1/285
|
0.00%
0/142
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/285
|
0.70%
1/142
|
|
Investigations
Blood pressure increased
|
0.70%
2/285
|
1.4%
2/142
|
|
Investigations
Blood pressure systolic increased
|
0.35%
1/285
|
0.00%
0/142
|
|
Investigations
Blood triglycerides increased
|
0.35%
1/285
|
0.70%
1/142
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/285
|
0.70%
1/142
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.35%
1/285
|
0.70%
1/142
|
|
Investigations
Heart rate increased
|
0.35%
1/285
|
0.70%
1/142
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/285
|
0.70%
1/142
|
|
Investigations
Thyroxine free decreased
|
0.35%
1/285
|
0.00%
0/142
|
|
Investigations
Transaminases increased
|
0.35%
1/285
|
0.00%
0/142
|
|
Investigations
Weight decreased
|
0.70%
2/285
|
1.4%
2/142
|
|
Investigations
Weight increased
|
1.4%
4/285
|
2.8%
4/142
|
|
Investigations
White blood cell count increased
|
0.35%
1/285
|
0.00%
0/142
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.5%
10/285
|
1.4%
2/142
|
|
Metabolism and nutrition disorders
Gout
|
0.35%
1/285
|
0.00%
0/142
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.35%
1/285
|
0.00%
0/142
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/285
|
0.70%
1/142
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.35%
1/285
|
0.00%
0/142
|
|
Metabolism and nutrition disorders
Increased appetite
|
1.1%
3/285
|
1.4%
2/142
|
|
Metabolism and nutrition disorders
Arthralgia
|
0.70%
2/285
|
1.4%
2/142
|
|
Metabolism and nutrition disorders
Back pain
|
3.5%
10/285
|
1.4%
2/142
|
|
Metabolism and nutrition disorders
Bursitis
|
0.35%
1/285
|
0.00%
0/142
|
|
Metabolism and nutrition disorders
Flank pain
|
0.35%
1/285
|
0.70%
1/142
|
|
Metabolism and nutrition disorders
Joint stiffness
|
0.35%
1/285
|
0.70%
1/142
|
|
Metabolism and nutrition disorders
Joint swelling
|
0.70%
2/285
|
1.4%
2/142
|
|
Metabolism and nutrition disorders
Muscle spasms
|
1.4%
4/285
|
0.70%
1/142
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.35%
1/285
|
0.00%
0/142
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.35%
1/285
|
0.00%
0/142
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.70%
2/285
|
0.70%
1/142
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/285
|
1.4%
2/142
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.70%
2/285
|
0.00%
0/142
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.70%
2/285
|
0.70%
1/142
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.35%
1/285
|
0.70%
1/142
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.35%
1/285
|
0.00%
0/142
|
|
Nervous system disorders
Aphasia
|
0.35%
1/285
|
0.00%
0/142
|
|
Nervous system disorders
Burning sensation
|
0.35%
1/285
|
0.00%
0/142
|
|
Nervous system disorders
Crying
|
0.00%
0/285
|
0.70%
1/142
|
|
Nervous system disorders
Disturbance in attention
|
1.1%
3/285
|
0.00%
0/142
|
|
Nervous system disorders
Dizziness
|
9.8%
28/285
|
4.2%
6/142
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/285
|
1.4%
2/142
|
|
Nervous system disorders
Dysgeusia
|
0.35%
1/285
|
0.00%
0/142
|
|
Nervous system disorders
Fine motor delay
|
0.35%
1/285
|
0.00%
0/142
|
|
Nervous system disorders
Headache
|
15.1%
43/285
|
14.8%
21/142
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/285
|
0.70%
1/142
|
|
Nervous system disorders
Hypoaesthesia
|
0.35%
1/285
|
0.00%
0/142
|
|
Nervous system disorders
Lethargy
|
0.70%
2/285
|
0.00%
0/142
|
|
Nervous system disorders
Migraine
|
1.4%
4/285
|
1.4%
2/142
|
|
Nervous system disorders
Paresthesia
|
1.8%
5/285
|
0.70%
1/142
|
|
Nervous system disorders
Presyncope
|
0.35%
1/285
|
0.00%
0/142
|
|
Nervous system disorders
Sedation
|
1.4%
4/285
|
0.00%
0/142
|
|
Nervous system disorders
Sinus headache
|
0.70%
2/285
|
0.00%
0/142
|
|
Nervous system disorders
Somnolence
|
6.3%
18/285
|
2.1%
3/142
|
|
Nervous system disorders
Syncope
|
0.35%
1/285
|
0.70%
1/142
|
|
Nervous system disorders
Tension headache
|
0.35%
1/285
|
0.00%
0/142
|
|
Nervous system disorders
Tremor
|
1.8%
5/285
|
0.00%
0/142
|
|
Psychiatric disorders
Abnormal dreams
|
0.70%
2/285
|
2.1%
3/142
|
|
Psychiatric disorders
Anorgasmia
|
0.35%
1/285
|
0.00%
0/142
|
|
Psychiatric disorders
Anxiety
|
1.4%
4/285
|
0.70%
1/142
|
|
Psychiatric disorders
Bereavement reaction
|
0.35%
1/285
|
0.00%
0/142
|
|
Psychiatric disorders
Bruxism
|
0.70%
2/285
|
0.00%
0/142
|
|
Psychiatric disorders
Depression
|
0.70%
2/285
|
0.00%
0/142
|
|
Psychiatric disorders
Euphoric mood
|
0.35%
1/285
|
0.00%
0/142
|
|
Psychiatric disorders
Initial insomnia
|
0.70%
2/285
|
0.00%
0/142
|
|
Psychiatric disorders
Insomnia
|
4.6%
13/285
|
3.5%
5/142
|
|
Psychiatric disorders
Libido decreased
|
1.8%
5/285
|
0.00%
0/142
|
|
Psychiatric disorders
Libido increased
|
0.35%
1/285
|
0.00%
0/142
|
|
Psychiatric disorders
Major depression
|
0.00%
0/285
|
0.70%
1/142
|
|
Psychiatric disorders
Middle insomnia
|
0.70%
2/285
|
0.00%
0/142
|
|
Psychiatric disorders
Nervousness
|
0.35%
1/285
|
0.70%
1/142
|
|
Psychiatric disorders
Panic attack
|
0.35%
1/285
|
0.00%
0/142
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/285
|
0.70%
1/142
|
|
Psychiatric disorders
Sleep disorder
|
0.35%
1/285
|
0.00%
0/142
|
|
Psychiatric disorders
Violence-related symptom
|
0.00%
0/285
|
0.70%
1/142
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/285
|
0.70%
1/142
|
|
Psychiatric disorders
Pollakiuria
|
0.70%
2/285
|
0.70%
1/142
|
|
Reproductive system and breast disorders
Breast discharge
|
0.00%
0/285
|
0.70%
1/142
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.35%
1/285
|
0.00%
0/142
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/285
|
0.70%
1/142
|
|
Reproductive system and breast disorders
Ejaculation delayed
|
0.70%
2/285
|
0.00%
0/142
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.4%
4/285
|
0.70%
1/142
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/285
|
0.70%
1/142
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.70%
2/285
|
0.70%
1/142
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.35%
1/285
|
0.00%
0/142
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.35%
1/285
|
0.00%
0/142
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.35%
1/285
|
0.00%
0/142
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.35%
1/285
|
2.1%
3/142
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.35%
1/285
|
0.00%
0/142
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.35%
1/285
|
0.00%
0/142
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/285
|
0.70%
1/142
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/285
|
0.70%
1/142
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.35%
1/285
|
0.00%
0/142
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.35%
1/285
|
0.00%
0/142
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.1%
3/285
|
0.00%
0/142
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/285
|
0.70%
1/142
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
1.8%
5/285
|
0.00%
0/142
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/285
|
0.70%
1/142
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.1%
3/285
|
0.00%
0/142
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/285
|
0.70%
1/142
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/285
|
0.70%
1/142
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.4%
4/285
|
0.00%
0/142
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.70%
2/285
|
0.70%
1/142
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.70%
2/285
|
0.00%
0/142
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
3/285
|
0.70%
1/142
|
|
Vascular disorders
Hot flush
|
1.4%
4/285
|
1.4%
2/142
|
|
Vascular disorders
Hypertension
|
3.2%
9/285
|
0.00%
0/142
|
|
Vascular disorders
Hypotension
|
0.00%
0/285
|
0.70%
1/142
|
|
Infections and infestations
Sinusitis
|
0.35%
1/285
|
0.00%
0/142
|
|
Investigations
Tri-iodothyronine decreased
|
0.35%
1/285
|
0.00%
0/142
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER