Generalized Anxiety Disorder Adjunct Study | NCT00534599

Label	Type	Description	Intervention Names
1	Other	Adjunctive Placebo Seroquel XR to anxiety treatment	Drug: Placebo
2	Experimental	Adjunctive Seroquel XR to anxiety treatment	Drug: quetiapine fumarate XR

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	oral	1
quetiapine fumarate XR

Measure	Description	Time Frame
Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score	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.	Baseline (randomization) and then 8 weeks

Measure	Description	Time Frame
Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score	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.	Baseline (randomization) and then 8 weeks

Name	Affiliation	Role
Martin Brecher, MD	AstraZeneca	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama		United States
Research Site

PubMed Identifier	Type	Citation	Retractions
24660224	Derived	Khan A, Atkinson S, Mezhebovsky I, She F, Leathers T, Pathak S. Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in patients with generalized anxiety disorder and a history of inadequate treatment response: a randomized, double-blind study. Ann Clin Psychiatry. 2014 Feb;26(1):3-18.
24199224	Derived

ID	Title	Description
FG000	Quetiapine XR	50 mg to 300 mg extended release tablets once daily
FG001	Placebo	Matching placebo tablets once daily

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score

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.

Results participant numbers are based on Modified Intention to Treat (MITT) population set; The participants in the overall study are participants randomized.

Posted

Least Squares Mean

95% Confidence Interval

units on scale

Baseline (randomization) and then 8 weeks

ID	Title	Description
OG000	Quetiapine XR	50 mg to 300 mg extended release tablets once daily
OG001	Placebo	Matching placebo tablets once daily

Units	Counts
Participants	OG000204 OG001198

Title

Denominators

Categories

Title	Measurements
	OG000-10.74(-12.01 to -9.47) OG001-9.61(-10.89 to -8.32)

Secondary

Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score

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.

Posted

Least Squares Mean

95% Confidence Interval

LS mean change from randomization

Baseline (randomization) and then 8 weeks

ID	Title	Description
OG000	Quetiapine XR	50 mg to 300 mg extended release tablets once daily
OG001	Placebo	Matching placebo tablets once daily

Units	Counts
Participants	OG000

Secondary

Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of "Much/Very Much Improved" at Week 8

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.

Posted

Number

Participants

Baseline (randomization) and then 8 weeks

ID	Title	Description
OG000	Quetiapine XR	50 mg to 300 mg extended release tablets once daily
OG001	Placebo	Matching placebo tablets once daily

Units	Counts
Participants	OG000

Secondary

Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score

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.

Posted

Least Squares Mean

95% Confidence Interval

LS mean change from randomization

Baseline (randomization) and then 8 weeks

ID	Title	Description
OG000	Quetiapine XR	50 mg to 300 mg extended release tablets once daily
OG001	Placebo	Matching placebo tablets once daily

Units	Counts
Participants	OG000

Secondary

Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score

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.

Posted

Least Squares Mean

95% Confidence Interval

LS mean change from randomization

Baseline (randomization) and then 8 weeks

ID	Title	Description
OG000	Quetiapine XR	50 mg to 300 mg extended release tablets once daily
OG001	Placebo	Matching placebo tablets once daily

Units	Counts
Participants	OG000

Secondary

Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8

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.

Posted

Number

Participants

Baseline (randomization) and then 8 weeks

ID	Title	Description
OG000	Quetiapine XR	50 mg to 300 mg extended release tablets once daily
OG001	Placebo	Matching placebo tablets once daily

Units	Counts
Participants	OG000

Secondary

Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8

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.

Posted

Number

Participants

Baseline (randomization) and then 8 weeks

ID	Title	Description
OG000	Quetiapine XR	50 mg to 300 mg extended release tablets once daily
OG001	Placebo	Matching placebo tablets once daily

Units	Counts
Participants	OG000

Secondary

Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score

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.

Posted

Least Squares Mean

95% Confidence Interval

LS mean change from randomization

Baseline (randomization) and then 8 weeks

ID	Title	Description
OG000	Quetiapine XR	50 mg to 300 mg extended release tablets once daily
OG001	Placebo	Matching placebo tablets once daily

Units	Counts
Participants	OG000

Secondary

Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score

Results based on MITT population with available data for this outcome measure.

Posted

Mean

Standard Deviation

Mean change from randomization

Baseline (randomization) and then 8 weeks

ID	Title	Description
OG000	Quetiapine XR	50 mg to 300 mg extended release tablets once daily
OG001	Placebo	Matching placebo tablets once daily

Units	Counts
Participants	OG000

Secondary

Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score

Results based on MITT population with available data for this outcome measure.

Posted

Mean

Standard Deviation

Mean change from randomization

Baseline (randomization) and then 8 weeks

ID	Title	Description
OG000	Quetiapine XR	50 mg to 300 mg extended release tablets once daily
OG001	Placebo	Matching placebo tablets once daily

Units	Counts
Participants	OG000

Secondary

Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score

Results based on MITT population with available data for this outcome measure.

Posted

Least Squares Mean

95% Confidence Interval

LS mean change from randomization

Baseline (randomization) and then 8 weeks

ID	Title	Description
OG000	Quetiapine XR	50 mg to 300 mg extended release tablets once daily
OG001	Placebo	Matching placebo tablets once daily

Units	Counts
Participants	OG000

Secondary

Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score

Posted

Least Squares Mean

95% Confidence Interval

LS mean change from randomization

Baseline (randomization) and then 8 weeks

ID	Title	Description
OG000	Quetiapine XR	50 mg to 300 mg extended release tablets once daily
OG001	Placebo	Matching placebo tablets once daily

Units	Counts
Participants	OG000

Secondary

Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score

Results based on MITT population with available data for this outcome measure.

Posted

Least Squares Mean

95% Confidence Interval

LS mean change from randomization

Baseline (randomization) and then 8 weeks

ID	Title	Description
OG000	Quetiapine XR	50 mg to 300 mg extended release tablets once daily
OG001	Placebo	Matching placebo tablets once daily

Units	Counts
Participants	OG000

Secondary

Least Square Mean Change From Randomization to Week 1 in CGI-S Score

Results based on MITT population with available data for this outcome measure.

Posted

Least Squares Mean

95% Confidence Interval

LS mean change from randomization

Baseline (randomization) and then 8 weeks

ID	Title	Description
OG000	Quetiapine XR	50 mg to 300 mg extended release tablets once daily
OG001	Placebo	Matching placebo tablets once daily

Units	Counts
Participants	OG000

Secondary

Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1

Results based on MITT population with available data for this outcome measure.

Posted

Number

Participants

Baseline (randomization) and then 8 weeks

ID	Title	Description
OG000	Quetiapine XR	50 mg to 300 mg extended release tablets once daily
OG001	Placebo	Matching placebo tablets once daily

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Palpitations	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected209 at risk EG0011 affected200 at risk
Sinus Arrhythmia	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Supraventricular Extrasystoles	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0011 affected200 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0011 affected200 at risk
Blepharitis	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Blepharospasm	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Conjunctivitis	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0010 affected200 at risk
Dry Eye	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Vision Blurred	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0010 affected200 at risk
Abdominal Discomfort	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0010 affected200 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0011 affected200 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0012 affected200 at risk
Abnormal Faeces	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00013 affected209 at risk EG0018 affected200 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected209 at risk EG0016 affected200 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00049 affected209 at risk EG00116 affected200 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected209 at risk EG0013 affected200 at risk
Flatulence	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0011 affected200 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0010 affected200 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00012 affected209 at risk EG00112 affected200 at risk
Stomach Discomfort	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0010 affected200 at risk
Toothache	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0011 affected200 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected209 at risk EG0013 affected200 at risk
Chest Discomfort	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0012 affected200 at risk
Chest Pain	General disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0010 affected200 at risk
Fatigue	General disorders	MedDRA 11.0	Systematic Assessment	EG00020 affected209 at risk EG0018 affected200 at risk
Gait Disturbance	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Irritability	General disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected209 at risk EG0011 affected200 at risk
Malaise	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Oedema	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Pyrexia	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Sluggishness	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Thirst	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Hypersensitivity	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Seasonal Allergy	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected209 at risk EG0010 affected200 at risk
Breast Infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Bronchitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Conjunctivitis Infective	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Cystitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Enterobiasis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Herpes Zoster	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Influenza	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0004 affected209 at risk EG0012 affected200 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0007 affected209 at risk EG00117 affected200 at risk
Otitis Externa	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Pharyngitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0011 affected200 at risk
Rhinovirus Infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Sinusitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0005 affected209 at risk EG0014 affected200 at risk
Tooth Abscess	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0011 affected200 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0008 affected209 at risk EG0015 affected200 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0004 affected209 at risk EG0012 affected200 at risk
Viral Infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0011 affected200 at risk
Joint Sprain	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Thermal Burn	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Blood Cholesterol Increased	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Blood Prolactin Increased	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Blood Triglycerides Increased	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Electrocardiogram QT Prolonged	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Electrocardiogram T Wave Amplitude Decreased	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Glycosylated Haemoglobin Increased	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0011 affected200 at risk
Lipids Increased	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Neutrophil Count Decreased	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Weight Decreased	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0012 affected200 at risk
Weight Increased	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0008 affected209 at risk EG0012 affected200 at risk
White Blood Cell Count Decreased	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Glucose Tolerance Impaired	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Increased Appetite	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected209 at risk EG0011 affected200 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0012 affected200 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected209 at risk EG0014 affected200 at risk
Contusion	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Joint Effusion	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Joint Stiffness	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Muscle Contracture	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0012 affected200 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0015 affected200 at risk
Muscle Tightness	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0011 affected200 at risk
Muscle Twitching	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0011 affected200 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0012 affected200 at risk
Musculoskeletal Stiffness	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected209 at risk EG0010 affected200 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected209 at risk EG0012 affected200 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected209 at risk EG0010 affected200 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0011 affected200 at risk
Fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Uterine Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Akathisia	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Amnesia	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Balance Disorder	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Disturbance In Attention	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Dizziness	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00022 affected209 at risk EG0019 affected200 at risk
Dysarthria	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Dysgeusia	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0010 affected200 at risk
Headache	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00024 affected209 at risk EG00121 affected200 at risk
Hypersomnia	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0010 affected200 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0011 affected200 at risk
Lethargy	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected209 at risk EG0010 affected200 at risk
Migraine	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Paraesthesia	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected209 at risk EG0011 affected200 at risk
Psychomotor Hyperactivity	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0011 affected200 at risk
Restless Legs Syndrome	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0010 affected200 at risk
Sedation	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00026 affected209 at risk EG0015 affected200 at risk
Somnolence	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00047 affected209 at risk EG00124 affected200 at risk
Speech Disorder	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Tension Headache	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0010 affected200 at risk
Tremor	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected209 at risk EG0011 affected200 at risk
Abnormal Dreams	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected209 at risk EG0012 affected200 at risk
Agitation	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0010 affected200 at risk
Anxiety	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0011 affected200 at risk
Confusional State	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Crying	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Depressed Mood	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Depression	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected209 at risk EG0013 affected200 at risk
Generalised Anxiety Disorder	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0012 affected200 at risk
Initial Insomnia	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Insomnia	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG00015 affected209 at risk EG0013 affected200 at risk
Libido Decreased	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected209 at risk EG0010 affected200 at risk
Nightmare	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0011 affected200 at risk
Restlessness	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected209 at risk EG0011 affected200 at risk
Sleep Disorder	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0010 affected200 at risk
Dysuria	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Ejaculation Delayed	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0011 affected200 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected209 at risk EG0010 affected200 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Pharyngolaryngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0013 affected200 at risk
Sinus Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0011 affected200 at risk
Dermatitis Contact	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Night Sweats	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Rash Pruritic	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Sebaceous Cyst Excision	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk
Hot Flush	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected209 at risk EG0011 affected200 at risk
Hypertension	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected209 at risk EG0011 affected200 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected209 at risk EG0010 affected200 at risk

ID	Title	Description
BG000	Quetiapine XR	50 mg to 300 mg extended release tablets once daily
BG001	Placebo	Matching placebo tablets once daily
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Quetiapine XR	50 mg to 300 mg extended release tablets once daily			0	209	154	209
EG001	Placebo	Matching placebo tablets once daily			0	200	120	200

ID	Term
D001008	Anxiety Disorders
D000098647	Generalized Anxiety Disorder