Generalized Anxiety Disorder Adjunct Study
Study Details
Study Description
Brief Summary
This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the treatment of Generalized Anxiety Disorder in patients with partial or no response to SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with placebo
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: 1 Adjunctive Placebo Seroquel XR to anxiety treatment |
Drug: Placebo
oral
|
Experimental: 2 Adjunctive Seroquel XR to anxiety treatment |
Drug: quetiapine fumarate XR
oral
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score [Baseline (randomization) and then 8 weeks]
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.
Secondary Outcome Measures
- Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score [Baseline (randomization) and then 8 weeks]
The 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.
- Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of "Much/Very Much Improved" at Week 8 [Baseline (randomization) and then 8 weeks]
This 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.
- Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score [Baseline (randomization) and then 8 weeks]
The 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.
- Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score [Baseline (randomization) and then 8 weeks]
The 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.
- Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8 [Baseline (randomization) and then 8 weeks]
Hamilton 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.
- Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8 [Baseline (randomization) and then 8 weeks]
Hamilton 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.
- Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score [Baseline (randomization) and then 8 weeks]
The 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.
- Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score [Baseline (randomization) and then 8 weeks]
Results based on MITT population with available data for this outcome measure.
- Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score [Baseline (randomization) and then 8 weeks]
Results based on MITT population with available data for this outcome measure.
- Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score [Baseline (randomization) and then 8 weeks]
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 Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score [Baseline (randomization) and then 8 weeks]
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 Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score [Baseline (randomization) and then 8 weeks]
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 Change From Randomization to Week 1 in CGI-S Score [Baseline (randomization) and then 8 weeks]
Results based on MITT population with available data for this outcome measure.
- Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1 [Baseline (randomization) and then 8 weeks]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
Provision of Informed Consent
-
Documented diagnosis of Generalized Anxiety Disorder
-
Female patients must not be pregnant and be willing to use a reliable method of birth control
-
Be able to understand and comply with study requirements
Exclusion Criteria:
Other psychiatric disorders that could confound the study results, as judged by the study doctor
-
Moderate to severe depression
-
Other clinically relevant diseases, as judged by the study doctor
-
Medication that you are taking, as judged by the study doctor
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Research Site | Birmingham | Alabama | United States | |
2 | Research Site | Little Rock | Arkansas | United States | |
3 | Research Site | Beverly Hills | California | United States | |
4 | Research Site | Encino | California | United States | |
5 | Research Site | Fresno | California | United States | |
6 | Research Site | La Mesa | California | United States | |
7 | Research Site | Oceanside | California | United States | |
8 | Research Site | Redlands | California | United States | |
9 | Research Site | San Diego | California | United States | |
10 | Research Site | San Francisco | California | United States | |
11 | Research Site | Sherman Oaks | California | United States | |
12 | Research Site | Bradenton | Florida | United States | |
13 | Research Site | Dayton | Florida | United States | |
14 | Research Site | Hialeah | Florida | United States | |
15 | Research Site | Jacksonville | Florida | United States | |
16 | Research Site | Maitland | Florida | United States | |
17 | Research Site | Miami | Florida | United States | |
18 | Research Site | North Miami | Florida | United States | |
19 | Research Site | Orlando | Florida | United States | |
20 | Research Site | Tampa | Florida | United States | |
21 | Research Site | West Palm Beach | Florida | United States | |
22 | Research Site | Atlanta | Georgia | United States | |
23 | Research Site | Columbus | Georgia | United States | |
24 | Research Site | Chicago | Illinois | United States | |
25 | Research Site | Lafayette | Indiana | United States | |
26 | Research Site | Merrillville | Indiana | United States | |
27 | Research Site | Terre Haute | Indiana | United States | |
28 | Research Site | Prairie Village | Kansas | United States | |
29 | Research Site | Owenboro | Kentucky | United States | |
30 | Research Site | New Orleans | Louisiana | United States | |
31 | Research Site | Rockville | Maryland | United States | |
32 | Research Site | Boston | Massachusetts | United States | |
33 | Research Site | Cherry Hill | New Jersey | United States | |
34 | Research Site | Clementon | New Jersey | United States | |
35 | Research Site | Brooklyn | New York | United States | |
36 | Research Site | Cedarhurst | New York | United States | |
37 | Research Site | Fresh Meadows | New York | United States | |
38 | Research Site | New York | New York | United States | |
39 | Research Site | Rochester | New York | United States | |
40 | Research Site | Staten Island | New York | United States | |
41 | Research Site | Toledo | Ohio | United States | |
42 | Research Site | Oklahoma City | Oklahoma | United States | |
43 | Research Site | Portland | Oregon | United States | |
44 | Research Site | Salem | Oregon | United States | |
45 | Research Site | Philadelphia | Pennsylvania | United States | |
46 | Research Site | Memphis | Tennessee | United States | |
47 | Research Site | Houston | Texas | United States | |
48 | Research Site | San Antonio | Texas | United States | |
49 | Research Site | Witchita Falls | Texas | United States | |
50 | Research Site | Richmond | Virginia | United States | |
51 | Research Site | Bellevue | Washington | United States | |
52 | Research Site | Seattle | Washington | United States | |
53 | Research Site | Spokane | Washington | United States |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Martin Brecher, MD, AstraZeneca
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D1441L00016
Study Results
Participant Flow
Recruitment Details | Patient enrollment from 31 August 2007 to 02 September 2008 |
---|---|
Pre-assignment Detail | Wash-out period of up to 35 days for discontinuation of prohibited medications |
Arm/Group Title | Quetiapine XR | Placebo |
---|---|---|
Arm/Group Description | 50 mg to 300 mg extended release tablets once daily | Matching placebo tablets once daily |
Period Title: Overall Study | ||
STARTED | 209 | 200 |
COMPLETED | 152 | 168 |
NOT COMPLETED | 57 | 32 |
Baseline Characteristics
Arm/Group Title | Quetiapine XR | Placebo | Total |
---|---|---|---|
Arm/Group Description | 50 mg to 300 mg extended release tablets once daily | Matching placebo tablets once daily | Total of all reporting groups |
Overall Participants | 204 | 198 | 402 |
Age (Years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Years] |
46.6
(12.1)
|
44.2
(10.9)
|
44.4
(11.5)
|
Sex: Female, Male (Count of Participants) | |||
Female |
146
71.6%
|
150
75.8%
|
296
73.6%
|
Male |
58
28.4%
|
48
24.2%
|
106
26.4%
|
Outcome Measures
Title | Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score |
---|---|
Description | 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. |
Time Frame | Baseline (randomization) and then 8 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Results participant numbers are based on Modified Intention to Treat (MITT) population set; The participants in the overall study are participants randomized. |
Arm/Group Title | Quetiapine XR | Placebo |
---|---|---|
Arm/Group Description | 50 mg to 300 mg extended release tablets once daily | Matching placebo tablets once daily |
Measure Participants | 204 | 198 |
Least Squares Mean (95% Confidence Interval) [units on scale] |
-10.74
|
-9.61
|
Title | Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score |
---|---|
Description | The 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. |
Time Frame | Baseline (randomization) and then 8 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Quetiapine XR | Placebo |
---|---|---|
Arm/Group Description | 50 mg to 300 mg extended release tablets once daily | Matching placebo tablets once daily |
Measure Participants | 204 | 198 |
Least Squares Mean (95% Confidence Interval) [LS mean change from randomization] |
-1.36
|
-1.13
|
Title | Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of "Much/Very Much Improved" at Week 8 |
---|---|
Description | This 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. |
Time Frame | Baseline (randomization) and then 8 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Quetiapine XR | Placebo |
---|---|---|
Arm/Group Description | 50 mg to 300 mg extended release tablets once daily | Matching placebo tablets once daily |
Measure Participants | 204 | 198 |
Number [Participants] |
114
55.9%
|
97
49%
|
Title | Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score |
---|---|
Description | The 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. |
Time Frame | Baseline (randomization) and then 8 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Quetiapine XR | Placebo |
---|---|---|
Arm/Group Description | 50 mg to 300 mg extended release tablets once daily | Matching placebo tablets once daily |
Measure Participants | 204 | 198 |
Least Squares Mean (95% Confidence Interval) [LS mean change from randomization] |
-6.09
|
-5.21
|
Title | Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score |
---|---|
Description | The 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. |
Time Frame | Baseline (randomization) and then 8 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Quetiapine XR | Placebo |
---|---|---|
Arm/Group Description | 50 mg to 300 mg extended release tablets once daily | Matching placebo tablets once daily |
Measure Participants | 204 | 198 |
Least Squares Mean (95% Confidence Interval) [LS mean change from randomization] |
-4.63
|
-4.38
|
Title | Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8 |
---|---|
Description | Hamilton 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. |
Time Frame | Baseline (randomization) and then 8 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Quetiapine XR | Placebo |
---|---|---|
Arm/Group Description | 50 mg to 300 mg extended release tablets once daily | Matching placebo tablets once daily |
Measure Participants | 204 | 198 |
Number [Participants] |
84
41.2%
|
72
36.4%
|
Title | Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8 |
---|---|
Description | Hamilton 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. |
Time Frame | Baseline (randomization) and then 8 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Quetiapine XR | Placebo |
---|---|---|
Arm/Group Description | 50 mg to 300 mg extended release tablets once daily | Matching placebo tablets once daily |
Measure Participants | 204 | 198 |
Number [Participants] |
48
23.5%
|
34
17.2%
|
Title | Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score |
---|---|
Description | The 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. |
Time Frame | Baseline (randomization) and then 8 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Quetiapine XR | Placebo |
---|---|---|
Arm/Group Description | 50 mg to 300 mg extended release tablets once daily | Matching placebo tablets once daily |
Measure Participants | 202 | 194 |
Least Squares Mean (95% Confidence Interval) [LS mean change from randomization] |
7.33
|
6.43
|
Title | Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score |
---|---|
Description | Results based on MITT population with available data for this outcome measure. |
Time Frame | Baseline (randomization) and then 8 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Quetiapine XR | Placebo |
---|---|---|
Arm/Group Description | 50 mg to 300 mg extended release tablets once daily | Matching placebo tablets once daily |
Measure Participants | 179 | 174 |
Mean (Standard Deviation) [Mean change from randomization] |
0.30
(1.10)
|
0.40
(1.10)
|
Title | Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score |
---|---|
Description | Results based on MITT population with available data for this outcome measure. |
Time Frame | Baseline (randomization) and then 8 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Quetiapine XR | Placebo |
---|---|---|
Arm/Group Description | 50 mg to 300 mg extended release tablets once daily | Matching placebo tablets once daily |
Measure Participants | 204 | 198 |
Mean (Standard Deviation) [Mean change from randomization] |
0.30
(1.0)
|
0.20
(0.90)
|
Title | Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score |
---|---|
Description | 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. |
Time Frame | Baseline (randomization) and then 8 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Quetiapine XR | Placebo |
---|---|---|
Arm/Group Description | 50 mg to 300 mg extended release tablets once daily | Matching placebo tablets once daily |
Measure Participants | 195 | 191 |
Least Squares Mean (95% Confidence Interval) [LS mean change from randomization] |
-6.45
|
-4.47
|
Title | Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score |
---|---|
Description | 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. |
Time Frame | Baseline (randomization) and then 8 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Quetiapine XR | Placebo |
---|---|---|
Arm/Group Description | 50 mg to 300 mg extended release tablets once daily | Matching placebo tablets once daily |
Measure Participants | 195 | 191 |
Least Squares Mean (95% Confidence Interval) [LS mean change from randomization] |
-3.70
|
-2.46
|
Title | Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score |
---|---|
Description | 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. |
Time Frame | Baseline (randomization) and then 8 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Quetiapine XR | Placebo |
---|---|---|
Arm/Group Description | 50 mg to 300 mg extended release tablets once daily | Matching placebo tablets once daily |
Measure Participants | 195 | 191 |
Least Squares Mean (95% Confidence Interval) [LS mean change from randomization] |
-2.74
|
-2.0
|
Title | Least Square Mean Change From Randomization to Week 1 in CGI-S Score |
---|---|
Description | Results based on MITT population with available data for this outcome measure. |
Time Frame | Baseline (randomization) and then 8 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Quetiapine XR | Placebo |
---|---|---|
Arm/Group Description | 50 mg to 300 mg extended release tablets once daily | Matching placebo tablets once daily |
Measure Participants | 195 | 191 |
Least Squares Mean (95% Confidence Interval) [LS mean change from randomization] |
-0.56
|
-0.35
|
Title | Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1 |
---|---|
Description | 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. |
Time Frame | Baseline (randomization) and then 8 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Quetiapine XR | Placebo |
---|---|---|
Arm/Group Description | 50 mg to 300 mg extended release tablets once daily | Matching placebo tablets once daily |
Measure Participants | 195 | 191 |
Number [Participants] |
33
16.2%
|
22
11.1%
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Quetiapine XR | Placebo | ||
Arm/Group Description | 50 mg to 300 mg extended release tablets once daily | Matching placebo tablets once daily | ||
All Cause Mortality |
||||
Quetiapine XR | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Quetiapine XR | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/209 (0%) | 0/200 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Quetiapine XR | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 154/209 (73.7%) | 120/200 (60%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 0/209 (0%) | 1/200 (0.5%) | ||
Cardiac disorders | ||||
Palpitations | 3/209 (1.4%) | 1/200 (0.5%) | ||
Sinus Arrhythmia | 0/209 (0%) | 1/200 (0.5%) | ||
Supraventricular Extrasystoles | 1/209 (0.5%) | 0/200 (0%) | ||
Ear and labyrinth disorders | ||||
Tinnitus | 2/209 (1%) | 1/200 (0.5%) | ||
Vertigo | 1/209 (0.5%) | 1/200 (0.5%) | ||
Eye disorders | ||||
Blepharitis | 0/209 (0%) | 1/200 (0.5%) | ||
Blepharospasm | 1/209 (0.5%) | 0/200 (0%) | ||
Conjunctivitis | 2/209 (1%) | 0/200 (0%) | ||
Dry Eye | 0/209 (0%) | 1/200 (0.5%) | ||
Vision Blurred | 2/209 (1%) | 0/200 (0%) | ||
Gastrointestinal disorders | ||||
Abdominal Discomfort | 1/209 (0.5%) | 0/200 (0%) | ||
Abdominal Distension | 2/209 (1%) | 0/200 (0%) | ||
Abdominal Pain | 2/209 (1%) | 1/200 (0.5%) | ||
Abdominal Pain Upper | 2/209 (1%) | 2/200 (1%) | ||
Abnormal Faeces | 1/209 (0.5%) | 0/200 (0%) | ||
Constipation | 13/209 (6.2%) | 8/200 (4%) | ||
Diarrhoea | 6/209 (2.9%) | 6/200 (3%) | ||
Dry Mouth | 49/209 (23.4%) | 16/200 (8%) | ||
Dyspepsia | 6/209 (2.9%) | 3/200 (1.5%) | ||
Flatulence | 1/209 (0.5%) | 1/200 (0.5%) | ||
Gastrooesophageal Reflux Disease | 2/209 (1%) | 0/200 (0%) | ||
Haematochezia | 1/209 (0.5%) | 0/200 (0%) | ||
Nausea | 12/209 (5.7%) | 12/200 (6%) | ||
Stomach Discomfort | 2/209 (1%) | 0/200 (0%) | ||
Toothache | 1/209 (0.5%) | 1/200 (0.5%) | ||
Vomiting | 3/209 (1.4%) | 3/200 (1.5%) | ||
General disorders | ||||
Chest Discomfort | 1/209 (0.5%) | 2/200 (1%) | ||
Chest Pain | 2/209 (1%) | 0/200 (0%) | ||
Fatigue | 20/209 (9.6%) | 8/200 (4%) | ||
Gait Disturbance | 1/209 (0.5%) | 0/200 (0%) | ||
Irritability | 4/209 (1.9%) | 1/200 (0.5%) | ||
Malaise | 1/209 (0.5%) | 0/200 (0%) | ||
Oedema | 0/209 (0%) | 1/200 (0.5%) | ||
Pyrexia | 1/209 (0.5%) | 0/200 (0%) | ||
Sluggishness | 1/209 (0.5%) | 0/200 (0%) | ||
Thirst | 0/209 (0%) | 1/200 (0.5%) | ||
Immune system disorders | ||||
Hypersensitivity | 0/209 (0%) | 1/200 (0.5%) | ||
Seasonal Allergy | 3/209 (1.4%) | 0/200 (0%) | ||
Infections and infestations | ||||
Breast Infection | 1/209 (0.5%) | 0/200 (0%) | ||
Bronchitis | 1/209 (0.5%) | 0/200 (0%) | ||
Conjunctivitis Infective | 0/209 (0%) | 1/200 (0.5%) | ||
Cystitis | 1/209 (0.5%) | 0/200 (0%) | ||
Enterobiasis | 1/209 (0.5%) | 0/200 (0%) | ||
Gastroenteritis Viral | 0/209 (0%) | 1/200 (0.5%) | ||
Herpes Zoster | 1/209 (0.5%) | 0/200 (0%) | ||
Influenza | 4/209 (1.9%) | 2/200 (1%) | ||
Lower Respiratory Tract Infection | 0/209 (0%) | 1/200 (0.5%) | ||
Nasopharyngitis | 7/209 (3.3%) | 17/200 (8.5%) | ||
Otitis Externa | 1/209 (0.5%) | 0/200 (0%) | ||
Pharyngitis | 1/209 (0.5%) | 0/200 (0%) | ||
Respiratory Tract Infection | 1/209 (0.5%) | 1/200 (0.5%) | ||
Rhinovirus Infection | 1/209 (0.5%) | 0/200 (0%) | ||
Sinusitis | 5/209 (2.4%) | 4/200 (2%) | ||
Tooth Abscess | 1/209 (0.5%) | 1/200 (0.5%) | ||
Upper Respiratory Tract Infection | 8/209 (3.8%) | 5/200 (2.5%) | ||
Urinary Tract Infection | 4/209 (1.9%) | 2/200 (1%) | ||
Viral Infection | 1/209 (0.5%) | 1/200 (0.5%) | ||
Injury, poisoning and procedural complications | ||||
Joint Sprain | 0/209 (0%) | 1/200 (0.5%) | ||
Road Traffic Accident | 1/209 (0.5%) | 0/200 (0%) | ||
Thermal Burn | 0/209 (0%) | 1/200 (0.5%) | ||
Wound | 0/209 (0%) | 1/200 (0.5%) | ||
Blood Cholesterol Increased | 1/209 (0.5%) | 0/200 (0%) | ||
Blood Prolactin Increased | 0/209 (0%) | 1/200 (0.5%) | ||
Blood Triglycerides Increased | 1/209 (0.5%) | 0/200 (0%) | ||
Electrocardiogram QT Prolonged | 1/209 (0.5%) | 0/200 (0%) | ||
Electrocardiogram T Wave Amplitude Decreased | 1/209 (0.5%) | 0/200 (0%) | ||
Glycosylated Haemoglobin Increased | 1/209 (0.5%) | 1/200 (0.5%) | ||
Lipids Increased | 1/209 (0.5%) | 0/200 (0%) | ||
Neutrophil Count Decreased | 1/209 (0.5%) | 0/200 (0%) | ||
Weight Decreased | 0/209 (0%) | 2/200 (1%) | ||
Weight Increased | 8/209 (3.8%) | 2/200 (1%) | ||
White Blood Cell Count Decreased | 1/209 (0.5%) | 0/200 (0%) | ||
Metabolism and nutrition disorders | ||||
Dehydration | 1/209 (0.5%) | 0/200 (0%) | ||
Dyslipidaemia | 0/209 (0%) | 1/200 (0.5%) | ||
Glucose Tolerance Impaired | 1/209 (0.5%) | 0/200 (0%) | ||
Hyperlipidaemia | 1/209 (0.5%) | 0/200 (0%) | ||
Increased Appetite | 8/209 (3.8%) | 1/200 (0.5%) | ||
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 1/209 (0.5%) | 2/200 (1%) | ||
Back Pain | 4/209 (1.9%) | 4/200 (2%) | ||
Contusion | 0/209 (0%) | 1/200 (0.5%) | ||
Joint Effusion | 0/209 (0%) | 1/200 (0.5%) | ||
Joint Stiffness | 1/209 (0.5%) | 0/200 (0%) | ||
Muscle Contracture | 0/209 (0%) | 2/200 (1%) | ||
Muscle Spasms | 2/209 (1%) | 5/200 (2.5%) | ||
Muscle Tightness | 2/209 (1%) | 1/200 (0.5%) | ||
Muscle Twitching | 1/209 (0.5%) | 1/200 (0.5%) | ||
Musculoskeletal Pain | 0/209 (0%) | 2/200 (1%) | ||
Musculoskeletal Stiffness | 4/209 (1.9%) | 0/200 (0%) | ||
Myalgia | 3/209 (1.4%) | 2/200 (1%) | ||
Neck Pain | 3/209 (1.4%) | 0/200 (0%) | ||
Pain In Extremity | 1/209 (0.5%) | 1/200 (0.5%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Fibroma | 1/209 (0.5%) | 0/200 (0%) | ||
Uterine Leiomyoma | 0/209 (0%) | 1/200 (0.5%) | ||
Nervous system disorders | ||||
Akathisia | 0/209 (0%) | 1/200 (0.5%) | ||
Amnesia | 1/209 (0.5%) | 0/200 (0%) | ||
Balance Disorder | 1/209 (0.5%) | 0/200 (0%) | ||
Disturbance In Attention | 1/209 (0.5%) | 0/200 (0%) | ||
Dizziness | 22/209 (10.5%) | 9/200 (4.5%) | ||
Dysarthria | 1/209 (0.5%) | 0/200 (0%) | ||
Dysgeusia | 2/209 (1%) | 0/200 (0%) | ||
Headache | 24/209 (11.5%) | 21/200 (10.5%) | ||
Hypersomnia | 2/209 (1%) | 0/200 (0%) | ||
Hypoaesthesia | 2/209 (1%) | 1/200 (0.5%) | ||
Lethargy | 3/209 (1.4%) | 0/200 (0%) | ||
Migraine | 0/209 (0%) | 1/200 (0.5%) | ||
Paraesthesia | 5/209 (2.4%) | 1/200 (0.5%) | ||
Psychomotor Hyperactivity | 2/209 (1%) | 1/200 (0.5%) | ||
Restless Legs Syndrome | 2/209 (1%) | 0/200 (0%) | ||
Sedation | 26/209 (12.4%) | 5/200 (2.5%) | ||
Somnolence | 47/209 (22.5%) | 24/200 (12%) | ||
Speech Disorder | 0/209 (0%) | 1/200 (0.5%) | ||
Tension Headache | 2/209 (1%) | 0/200 (0%) | ||
Tremor | 3/209 (1.4%) | 1/200 (0.5%) | ||
Psychiatric disorders | ||||
Abnormal Dreams | 6/209 (2.9%) | 2/200 (1%) | ||
Agitation | 2/209 (1%) | 0/200 (0%) | ||
Anxiety | 1/209 (0.5%) | 1/200 (0.5%) | ||
Confusional State | 1/209 (0.5%) | 0/200 (0%) | ||
Crying | 1/209 (0.5%) | 0/200 (0%) | ||
Depressed Mood | 1/209 (0.5%) | 0/200 (0%) | ||
Depression | 3/209 (1.4%) | 3/200 (1.5%) | ||
Generalised Anxiety Disorder | 0/209 (0%) | 2/200 (1%) | ||
Initial Insomnia | 1/209 (0.5%) | 0/200 (0%) | ||
Insomnia | 15/209 (7.2%) | 3/200 (1.5%) | ||
Libido Decreased | 5/209 (2.4%) | 0/200 (0%) | ||
Nightmare | 2/209 (1%) | 1/200 (0.5%) | ||
Restlessness | 3/209 (1.4%) | 1/200 (0.5%) | ||
Sleep Disorder | 2/209 (1%) | 0/200 (0%) | ||
Renal and urinary disorders | ||||
Dysuria | 1/209 (0.5%) | 0/200 (0%) | ||
Reproductive system and breast disorders | ||||
Amenorrhoea | 1/209 (0.5%) | 0/200 (0%) | ||
Ejaculation Delayed | 1/209 (0.5%) | 0/200 (0%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Cough | 2/209 (1%) | 1/200 (0.5%) | ||
Dyspnoea | 3/209 (1.4%) | 0/200 (0%) | ||
Epistaxis | 1/209 (0.5%) | 0/200 (0%) | ||
Nasal Congestion | 1/209 (0.5%) | 0/200 (0%) | ||
Pharyngolaryngeal Pain | 0/209 (0%) | 3/200 (1.5%) | ||
Sinus Disorder | 1/209 (0.5%) | 0/200 (0%) | ||
Skin and subcutaneous tissue disorders | ||||
Acne | 2/209 (1%) | 1/200 (0.5%) | ||
Dermatitis Contact | 1/209 (0.5%) | 0/200 (0%) | ||
Night Sweats | 0/209 (0%) | 1/200 (0.5%) | ||
Rash Pruritic | 0/209 (0%) | 1/200 (0.5%) | ||
Urticaria | 1/209 (0.5%) | 0/200 (0%) | ||
Vascular disorders | ||||
Sebaceous Cyst Excision | 1/209 (0.5%) | 0/200 (0%) | ||
Hot Flush | 0/209 (0%) | 1/200 (0.5%) | ||
Hypertension | 2/209 (1%) | 1/200 (0.5%) | ||
Orthostatic Hypotension | 1/209 (0.5%) | 0/200 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Gerard Lynch |
---|---|
Organization | AstraZeneca |
Phone | |
AZtrial_results_posting@astrazeneca.com |
- D1441L00016