Trial Outcomes & Findings for Generalized Anxiety Disorder Adjunct Study (NCT NCT00534599)
NCT ID: NCT00534599
Last Updated: 2011-04-14
Results Overview
Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure. Least square mean of each treatment was adjusted for baseline value.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
409 participants
Primary outcome timeframe
Baseline (randomization) and then 8 weeks
Results posted on
2011-04-14
Participant Flow
Patient enrollment from 31 August 2007 to 02 September 2008
Wash-out period of up to 35 days for discontinuation of prohibited medications
Participant milestones
| Measure |
Quetiapine XR
50 mg to 300 mg extended release tablets once daily
|
Placebo
Matching placebo tablets once daily
|
|---|---|---|
|
Overall Study
STARTED
|
209
|
200
|
|
Overall Study
COMPLETED
|
152
|
168
|
|
Overall Study
NOT COMPLETED
|
57
|
32
|
Reasons for withdrawal
| Measure |
Quetiapine XR
50 mg to 300 mg extended release tablets once daily
|
Placebo
Matching placebo tablets once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
25
|
4
|
|
Overall Study
Incorrect enrollment
|
2
|
1
|
|
Overall Study
Mis-randomization
|
2
|
2
|
|
Overall Study
Developed study-specific d/c criteria
|
5
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Generalized anxiety disorder worsened
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
11
|
14
|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
|
Overall Study
Other
|
7
|
0
|
Baseline Characteristics
Generalized Anxiety Disorder Adjunct Study
Baseline characteristics by cohort
| Measure |
Quetiapine XR
n=204 Participants
50 mg to 300 mg extended release tablets once daily
|
Placebo
n=198 Participants
Matching placebo tablets once daily
|
Total
n=402 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
46.6 Years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
44.2 Years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
44.4 Years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (randomization) and then 8 weeksPopulation: Results participant numbers are based on Modified Intention to Treat (MITT) population set; The participants in the overall study are participants randomized.
Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure. Least square mean of each treatment was adjusted for baseline value.
Outcome measures
| Measure |
Quetiapine XR
n=204 Participants
50 mg to 300 mg extended release tablets once daily
|
Placebo
n=198 Participants
Matching placebo tablets once daily
|
|---|---|---|
|
Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
|
-10.74 units on scale
Interval -12.01 to -9.47
|
-9.61 units on scale
Interval -10.89 to -8.32
|
SECONDARY outcome
Timeframe: Baseline (randomization) and then 8 weeksThe CGI-S is assessed on a seven-point scale ranging from most extremely ill/very much worse (7) to normal/very much improved (1). Results based on MITT population with available data for this outcome measure.
Outcome measures
| Measure |
Quetiapine XR
n=204 Participants
50 mg to 300 mg extended release tablets once daily
|
Placebo
n=198 Participants
Matching placebo tablets once daily
|
|---|---|---|
|
Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score
|
-1.36 LS mean change from randomization
Interval -1.56 to -1.15
|
-1.13 LS mean change from randomization
Interval -1.34 to -0.93
|
SECONDARY outcome
Timeframe: Baseline (randomization) and then 8 weeksThis pertains to the CGI-I scale which rates improvement of anxiety on a scale from 1-7, with '1' showing the best improvement(Very Much Improved) and '7' showing the worst improvement (Very Much Worse) as compared to the baseline visit. A rating of '2' indicates 'Much Improved'. Results based on MITT population with available data for this outcome measure.
Outcome measures
| Measure |
Quetiapine XR
n=204 Participants
50 mg to 300 mg extended release tablets once daily
|
Placebo
n=198 Participants
Matching placebo tablets once daily
|
|---|---|---|
|
Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of "Much/Very Much Improved" at Week 8
|
114 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: Baseline (randomization) and then 8 weeksThe HAM-A psychic anxiety factor subscale is defined as the sum of the following 7 HAM-A factors: anxious mood, tension, fears, insomnia, intellectual, depressed mood and behavior at the interview (i.e.items 1-6 and 14, respectively) Results based on MITT population with available data for this outcome measure.
Outcome measures
| Measure |
Quetiapine XR
n=204 Participants
50 mg to 300 mg extended release tablets once daily
|
Placebo
n=198 Participants
Matching placebo tablets once daily
|
|---|---|---|
|
Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score
|
-6.09 LS mean change from randomization
Interval -6.81 to -5.37
|
-5.21 LS mean change from randomization
Interval -5.94 to -4.49
|
SECONDARY outcome
Timeframe: Baseline (randomization) and then 8 weeksThe HAM-A Somatic cluster subscale is defined as the sum of the following 7 HAM-A items: somatic (muscular), somatic (sensory), cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms and autonomic system (i.e. items 7-13 respectively). Results based on MITT population with available data for this outcome measure.
Outcome measures
| Measure |
Quetiapine XR
n=204 Participants
50 mg to 300 mg extended release tablets once daily
|
Placebo
n=198 Participants
Matching placebo tablets once daily
|
|---|---|---|
|
Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score
|
-4.63 LS mean change from randomization
Interval -5.25 to -4.02
|
-4.38 LS mean change from randomization
Interval -5.0 to -3.75
|
SECONDARY outcome
Timeframe: Baseline (randomization) and then 8 weeksHamilton Rating Scale for Anxiety (HAM-A) response is derived from the HAM-A total score and is defined as a decrease from baseline total HAM-A score of at least 50%. (1=Yes, 0=No) Results based on MITT population with available data for this outcome measure.
Outcome measures
| Measure |
Quetiapine XR
n=204 Participants
50 mg to 300 mg extended release tablets once daily
|
Placebo
n=198 Participants
Matching placebo tablets once daily
|
|---|---|---|
|
Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8
|
84 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: Baseline (randomization) and then 8 weeksHamilton Rating Scale for Anxiety (HAM-A) remission is derived from the HAM-A total score and is defined as a HAM-A total score of ≤7. 1=Yes, 0=No Results based on MITT population with available data for this outcome measure.
Outcome measures
| Measure |
Quetiapine XR
n=204 Participants
50 mg to 300 mg extended release tablets once daily
|
Placebo
n=198 Participants
Matching placebo tablets once daily
|
|---|---|---|
|
Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8
|
48 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Baseline (randomization) and then 8 weeksThe Q-LES-Q score is the sum of the first 14 items, larger values indicating a higher perceived quality of life enjoyment and satisfaction. This total score was converted to a % maximum score using the following scoring conversion: %Maximum score = (Total score-14)\*(100/560)rounded to an integer. Results based on MITT population with available data for this outcome measure.
Outcome measures
| Measure |
Quetiapine XR
n=202 Participants
50 mg to 300 mg extended release tablets once daily
|
Placebo
n=194 Participants
Matching placebo tablets once daily
|
|---|---|---|
|
Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score
|
7.33 LS mean change from randomization
Interval 5.4 to 9.26
|
6.43 LS mean change from randomization
Interval 4.46 to 8.4
|
SECONDARY outcome
Timeframe: Baseline (randomization) and then 8 weeksResults based on MITT population with available data for this outcome measure.
Outcome measures
| Measure |
Quetiapine XR
n=179 Participants
50 mg to 300 mg extended release tablets once daily
|
Placebo
n=174 Participants
Matching placebo tablets once daily
|
|---|---|---|
|
Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score
|
0.30 Mean change from randomization
Standard Deviation 1.10
|
0.40 Mean change from randomization
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Baseline (randomization) and then 8 weeksResults based on MITT population with available data for this outcome measure.
Outcome measures
| Measure |
Quetiapine XR
n=204 Participants
50 mg to 300 mg extended release tablets once daily
|
Placebo
n=198 Participants
Matching placebo tablets once daily
|
|---|---|---|
|
Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score
|
0.30 Mean change from randomization
Standard Deviation 1.0
|
0.20 Mean change from randomization
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Baseline (randomization) and then 8 weeksHamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure.
Outcome measures
| Measure |
Quetiapine XR
n=195 Participants
50 mg to 300 mg extended release tablets once daily
|
Placebo
n=191 Participants
Matching placebo tablets once daily
|
|---|---|---|
|
Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score
|
-6.45 LS mean change from randomization
Interval -7.5 to -5.41
|
-4.47 LS mean change from randomization
Interval -5.52 to -3.41
|
SECONDARY outcome
Timeframe: Baseline (randomization) and then 8 weeksHamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).Results based on MITT population with available data for this outcome measure.
Outcome measures
| Measure |
Quetiapine XR
n=195 Participants
50 mg to 300 mg extended release tablets once daily
|
Placebo
n=191 Participants
Matching placebo tablets once daily
|
|---|---|---|
|
Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score
|
-3.70 LS mean change from randomization
Interval -4.31 to -3.09
|
-2.46 LS mean change from randomization
Interval -3.08 to -1.84
|
SECONDARY outcome
Timeframe: Baseline (randomization) and then 8 weeksHamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure.
Outcome measures
| Measure |
Quetiapine XR
n=195 Participants
50 mg to 300 mg extended release tablets once daily
|
Placebo
n=191 Participants
Matching placebo tablets once daily
|
|---|---|---|
|
Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score
|
-2.74 LS mean change from randomization
Interval -3.27 to -2.21
|
-2.0 LS mean change from randomization
Interval -2.54 to -1.47
|
SECONDARY outcome
Timeframe: Baseline (randomization) and then 8 weeksResults based on MITT population with available data for this outcome measure.
Outcome measures
| Measure |
Quetiapine XR
n=195 Participants
50 mg to 300 mg extended release tablets once daily
|
Placebo
n=191 Participants
Matching placebo tablets once daily
|
|---|---|---|
|
Least Square Mean Change From Randomization to Week 1 in CGI-S Score
|
-0.56 LS mean change from randomization
Interval -0.69 to -0.43
|
-0.35 LS mean change from randomization
Interval -0.48 to -0.22
|
SECONDARY outcome
Timeframe: Baseline (randomization) and then 8 weeksHamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure.
Outcome measures
| Measure |
Quetiapine XR
n=195 Participants
50 mg to 300 mg extended release tablets once daily
|
Placebo
n=191 Participants
Matching placebo tablets once daily
|
|---|---|---|
|
Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1
|
33 Participants
|
22 Participants
|
Adverse Events
Quetiapine XR
Serious events: 0 serious events
Other events: 154 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 120 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Quetiapine XR
n=209 participants at risk
50 mg to 300 mg extended release tablets once daily
|
Placebo
n=200 participants at risk
Matching placebo tablets once daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/209
|
0.50%
1/200
|
|
Cardiac disorders
Palpitations
|
1.4%
3/209
|
0.50%
1/200
|
|
Cardiac disorders
Sinus Arrhythmia
|
0.00%
0/209
|
0.50%
1/200
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.48%
1/209
|
0.00%
0/200
|
|
Ear and labyrinth disorders
Tinnitus
|
0.96%
2/209
|
0.50%
1/200
|
|
Ear and labyrinth disorders
Vertigo
|
0.48%
1/209
|
0.50%
1/200
|
|
Eye disorders
Blepharitis
|
0.00%
0/209
|
0.50%
1/200
|
|
Eye disorders
Blepharospasm
|
0.48%
1/209
|
0.00%
0/200
|
|
Eye disorders
Conjunctivitis
|
0.96%
2/209
|
0.00%
0/200
|
|
Eye disorders
Dry Eye
|
0.00%
0/209
|
0.50%
1/200
|
|
Eye disorders
Vision Blurred
|
0.96%
2/209
|
0.00%
0/200
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.48%
1/209
|
0.00%
0/200
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.96%
2/209
|
0.00%
0/200
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.96%
2/209
|
0.50%
1/200
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.96%
2/209
|
1.0%
2/200
|
|
Gastrointestinal disorders
Abnormal Faeces
|
0.48%
1/209
|
0.00%
0/200
|
|
Gastrointestinal disorders
Constipation
|
6.2%
13/209
|
4.0%
8/200
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
6/209
|
3.0%
6/200
|
|
Gastrointestinal disorders
Dry Mouth
|
23.4%
49/209
|
8.0%
16/200
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
6/209
|
1.5%
3/200
|
|
Gastrointestinal disorders
Flatulence
|
0.48%
1/209
|
0.50%
1/200
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.96%
2/209
|
0.00%
0/200
|
|
Gastrointestinal disorders
Haematochezia
|
0.48%
1/209
|
0.00%
0/200
|
|
Gastrointestinal disorders
Nausea
|
5.7%
12/209
|
6.0%
12/200
|
|
Gastrointestinal disorders
Stomach Discomfort
|
0.96%
2/209
|
0.00%
0/200
|
|
Gastrointestinal disorders
Toothache
|
0.48%
1/209
|
0.50%
1/200
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
3/209
|
1.5%
3/200
|
|
General disorders
Chest Discomfort
|
0.48%
1/209
|
1.0%
2/200
|
|
General disorders
Chest Pain
|
0.96%
2/209
|
0.00%
0/200
|
|
General disorders
Fatigue
|
9.6%
20/209
|
4.0%
8/200
|
|
General disorders
Gait Disturbance
|
0.48%
1/209
|
0.00%
0/200
|
|
General disorders
Irritability
|
1.9%
4/209
|
0.50%
1/200
|
|
General disorders
Malaise
|
0.48%
1/209
|
0.00%
0/200
|
|
General disorders
Oedema
|
0.00%
0/209
|
0.50%
1/200
|
|
General disorders
Pyrexia
|
0.48%
1/209
|
0.00%
0/200
|
|
General disorders
Sluggishness
|
0.48%
1/209
|
0.00%
0/200
|
|
General disorders
Thirst
|
0.00%
0/209
|
0.50%
1/200
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/209
|
0.50%
1/200
|
|
Immune system disorders
Seasonal Allergy
|
1.4%
3/209
|
0.00%
0/200
|
|
Infections and infestations
Breast Infection
|
0.48%
1/209
|
0.00%
0/200
|
|
Infections and infestations
Bronchitis
|
0.48%
1/209
|
0.00%
0/200
|
|
Infections and infestations
Conjunctivitis Infective
|
0.00%
0/209
|
0.50%
1/200
|
|
Infections and infestations
Cystitis
|
0.48%
1/209
|
0.00%
0/200
|
|
Infections and infestations
Enterobiasis
|
0.48%
1/209
|
0.00%
0/200
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/209
|
0.50%
1/200
|
|
Infections and infestations
Herpes Zoster
|
0.48%
1/209
|
0.00%
0/200
|
|
Infections and infestations
Influenza
|
1.9%
4/209
|
1.0%
2/200
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/209
|
0.50%
1/200
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
7/209
|
8.5%
17/200
|
|
Infections and infestations
Otitis Externa
|
0.48%
1/209
|
0.00%
0/200
|
|
Infections and infestations
Pharyngitis
|
0.48%
1/209
|
0.00%
0/200
|
|
Infections and infestations
Respiratory Tract Infection
|
0.48%
1/209
|
0.50%
1/200
|
|
Infections and infestations
Rhinovirus Infection
|
0.48%
1/209
|
0.00%
0/200
|
|
Infections and infestations
Sinusitis
|
2.4%
5/209
|
2.0%
4/200
|
|
Infections and infestations
Tooth Abscess
|
0.48%
1/209
|
0.50%
1/200
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.8%
8/209
|
2.5%
5/200
|
|
Infections and infestations
Urinary Tract Infection
|
1.9%
4/209
|
1.0%
2/200
|
|
Infections and infestations
Viral Infection
|
0.48%
1/209
|
0.50%
1/200
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
0.00%
0/209
|
0.50%
1/200
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.48%
1/209
|
0.00%
0/200
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/209
|
0.50%
1/200
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/209
|
0.50%
1/200
|
|
Injury, poisoning and procedural complications
Blood Cholesterol Increased
|
0.48%
1/209
|
0.00%
0/200
|
|
Injury, poisoning and procedural complications
Blood Prolactin Increased
|
0.00%
0/209
|
0.50%
1/200
|
|
Injury, poisoning and procedural complications
Blood Triglycerides Increased
|
0.48%
1/209
|
0.00%
0/200
|
|
Injury, poisoning and procedural complications
Electrocardiogram QT Prolonged
|
0.48%
1/209
|
0.00%
0/200
|
|
Injury, poisoning and procedural complications
Electrocardiogram T Wave Amplitude Decreased
|
0.48%
1/209
|
0.00%
0/200
|
|
Injury, poisoning and procedural complications
Glycosylated Haemoglobin Increased
|
0.48%
1/209
|
0.50%
1/200
|
|
Injury, poisoning and procedural complications
Lipids Increased
|
0.48%
1/209
|
0.00%
0/200
|
|
Injury, poisoning and procedural complications
Neutrophil Count Decreased
|
0.48%
1/209
|
0.00%
0/200
|
|
Injury, poisoning and procedural complications
Weight Decreased
|
0.00%
0/209
|
1.0%
2/200
|
|
Injury, poisoning and procedural complications
Weight Increased
|
3.8%
8/209
|
1.0%
2/200
|
|
Injury, poisoning and procedural complications
White Blood Cell Count Decreased
|
0.48%
1/209
|
0.00%
0/200
|
|
Metabolism and nutrition disorders
Dehydration
|
0.48%
1/209
|
0.00%
0/200
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/209
|
0.50%
1/200
|
|
Metabolism and nutrition disorders
Glucose Tolerance Impaired
|
0.48%
1/209
|
0.00%
0/200
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.48%
1/209
|
0.00%
0/200
|
|
Metabolism and nutrition disorders
Increased Appetite
|
3.8%
8/209
|
0.50%
1/200
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.48%
1/209
|
1.0%
2/200
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.9%
4/209
|
2.0%
4/200
|
|
Musculoskeletal and connective tissue disorders
Contusion
|
0.00%
0/209
|
0.50%
1/200
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.00%
0/209
|
0.50%
1/200
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
0.48%
1/209
|
0.00%
0/200
|
|
Musculoskeletal and connective tissue disorders
Muscle Contracture
|
0.00%
0/209
|
1.0%
2/200
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.96%
2/209
|
2.5%
5/200
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
0.96%
2/209
|
0.50%
1/200
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
0.48%
1/209
|
0.50%
1/200
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/209
|
1.0%
2/200
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
1.9%
4/209
|
0.00%
0/200
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
3/209
|
1.0%
2/200
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
1.4%
3/209
|
0.00%
0/200
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.48%
1/209
|
0.50%
1/200
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.48%
1/209
|
0.00%
0/200
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.00%
0/209
|
0.50%
1/200
|
|
Nervous system disorders
Akathisia
|
0.00%
0/209
|
0.50%
1/200
|
|
Nervous system disorders
Amnesia
|
0.48%
1/209
|
0.00%
0/200
|
|
Nervous system disorders
Balance Disorder
|
0.48%
1/209
|
0.00%
0/200
|
|
Nervous system disorders
Disturbance In Attention
|
0.48%
1/209
|
0.00%
0/200
|
|
Nervous system disorders
Dizziness
|
10.5%
22/209
|
4.5%
9/200
|
|
Nervous system disorders
Dysarthria
|
0.48%
1/209
|
0.00%
0/200
|
|
Nervous system disorders
Dysgeusia
|
0.96%
2/209
|
0.00%
0/200
|
|
Nervous system disorders
Headache
|
11.5%
24/209
|
10.5%
21/200
|
|
Nervous system disorders
Hypersomnia
|
0.96%
2/209
|
0.00%
0/200
|
|
Nervous system disorders
Hypoaesthesia
|
0.96%
2/209
|
0.50%
1/200
|
|
Nervous system disorders
Lethargy
|
1.4%
3/209
|
0.00%
0/200
|
|
Nervous system disorders
Migraine
|
0.00%
0/209
|
0.50%
1/200
|
|
Nervous system disorders
Paraesthesia
|
2.4%
5/209
|
0.50%
1/200
|
|
Nervous system disorders
Psychomotor Hyperactivity
|
0.96%
2/209
|
0.50%
1/200
|
|
Nervous system disorders
Restless Legs Syndrome
|
0.96%
2/209
|
0.00%
0/200
|
|
Nervous system disorders
Sedation
|
12.4%
26/209
|
2.5%
5/200
|
|
Nervous system disorders
Somnolence
|
22.5%
47/209
|
12.0%
24/200
|
|
Nervous system disorders
Speech Disorder
|
0.00%
0/209
|
0.50%
1/200
|
|
Nervous system disorders
Tension Headache
|
0.96%
2/209
|
0.00%
0/200
|
|
Nervous system disorders
Tremor
|
1.4%
3/209
|
0.50%
1/200
|
|
Psychiatric disorders
Abnormal Dreams
|
2.9%
6/209
|
1.0%
2/200
|
|
Psychiatric disorders
Agitation
|
0.96%
2/209
|
0.00%
0/200
|
|
Psychiatric disorders
Anxiety
|
0.48%
1/209
|
0.50%
1/200
|
|
Psychiatric disorders
Confusional State
|
0.48%
1/209
|
0.00%
0/200
|
|
Psychiatric disorders
Crying
|
0.48%
1/209
|
0.00%
0/200
|
|
Psychiatric disorders
Depressed Mood
|
0.48%
1/209
|
0.00%
0/200
|
|
Psychiatric disorders
Depression
|
1.4%
3/209
|
1.5%
3/200
|
|
Psychiatric disorders
Generalised Anxiety Disorder
|
0.00%
0/209
|
1.0%
2/200
|
|
Psychiatric disorders
Initial Insomnia
|
0.48%
1/209
|
0.00%
0/200
|
|
Psychiatric disorders
Insomnia
|
7.2%
15/209
|
1.5%
3/200
|
|
Psychiatric disorders
Libido Decreased
|
2.4%
5/209
|
0.00%
0/200
|
|
Psychiatric disorders
Nightmare
|
0.96%
2/209
|
0.50%
1/200
|
|
Psychiatric disorders
Restlessness
|
1.4%
3/209
|
0.50%
1/200
|
|
Psychiatric disorders
Sleep Disorder
|
0.96%
2/209
|
0.00%
0/200
|
|
Renal and urinary disorders
Dysuria
|
0.48%
1/209
|
0.00%
0/200
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.48%
1/209
|
0.00%
0/200
|
|
Reproductive system and breast disorders
Ejaculation Delayed
|
0.48%
1/209
|
0.00%
0/200
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.96%
2/209
|
0.50%
1/200
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
3/209
|
0.00%
0/200
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.48%
1/209
|
0.00%
0/200
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.48%
1/209
|
0.00%
0/200
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/209
|
1.5%
3/200
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Disorder
|
0.48%
1/209
|
0.00%
0/200
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.96%
2/209
|
0.50%
1/200
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.48%
1/209
|
0.00%
0/200
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/209
|
0.50%
1/200
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.00%
0/209
|
0.50%
1/200
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.48%
1/209
|
0.00%
0/200
|
|
Vascular disorders
Sebaceous Cyst Excision
|
0.48%
1/209
|
0.00%
0/200
|
|
Vascular disorders
Hot Flush
|
0.00%
0/209
|
0.50%
1/200
|
|
Vascular disorders
Hypertension
|
0.96%
2/209
|
0.50%
1/200
|
|
Vascular disorders
Orthostatic Hypotension
|
0.48%
1/209
|
0.00%
0/200
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If Sponsor does not publish within 2 years after study completion, PI is permitted to publish, with confidential information removed from manuscript. Sponsor will have opportunity to review and approve publication at least 60 days prior to being submitted/disclosed. Sponsor can request, in writing, an additional 90 day embargo.
- Publication restrictions are in place
Restriction type: OTHER