Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 1:28 PM
Ignite Modification Date: 2025-12-25 @ 12:32 PM
NCT ID: NCT00113295
Description: Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
Frequency Threshold: 0
Time Frame: Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Study: NCT00113295
Study Brief: Combination of Paroxetine CR and Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16. None None 2 11 7 11 View
Placebo Augmentation of Continued Paroxetine Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level. None None 1 11 8 11 View
Paroxetine Individuals received paroxetine CR for 10 weeks in Phase 1 of the study, initiated at 12.5 mg and flexibly titrated up to a maximum of 62.5 mg/day by week 8. None None 0 50 6 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Migraine Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea and high fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Appetite Decrease NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headaches NON_SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Jittery/shaky/restless NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sedation NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sexual dysfunction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Trouble Sleeping NON_SYSTEMATIC_ASSESSMENT General disorders None View
Urinary hesitancy NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vivid Dreams NON_SYSTEMATIC_ASSESSMENT General disorders None View
Weight gain NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Akathisia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Difficulty Concentrating NON_SYSTEMATIC_ASSESSMENT General disorders None View
Forgetfulness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gas NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Irritability NON_SYSTEMATIC_ASSESSMENT General disorders None View
Myoclonic Jerks NON_SYSTEMATIC_ASSESSMENT General disorders None View
Morning Grogginess NON_SYSTEMATIC_ASSESSMENT General disorders None View
Spasm NON_SYSTEMATIC_ASSESSMENT General disorders None View
Appetite Increase NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tremor NON_SYSTEMATIC_ASSESSMENT General disorders None View
Increased Sleep NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sweating NON_SYSTEMATIC_ASSESSMENT General disorders None View