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: 2025-12-25 @ 1:08 AM
Ignite Modification Date: 2025-12-25 @ 11:20 PM
NCT ID: NCT00389493
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00389493
Study Brief: Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive 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
Treatment With Exposure/Response Prevention Participants received exposure and response prevention therapy Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response. Mean Y-BOCS score measured at week 8 None None 0 40 22 40 View
Treatment With Pill Placebo Participants received treatment with the placebo Placebo : Placebo capsules will be identical in appearance to those of risperidone. Mean Y-BOCS score measured at week 8 None None 0 20 13 20 View
Treatment With Risperidone Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8 None None 0 40 30 40 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Nausea None Gastrointestinal disorders None View
Sweating None General disorders None View
Photophobia None Eye disorders None View
Constipation None Gastrointestinal disorders None View
Lightheadedness None Nervous system disorders None View
Dry Mouth None Gastrointestinal disorders None View
Blurry Vision None Eye disorders None View
Decreased Libido None Reproductive system and breast disorders None View
Anorgasmia/Erectile Failure None Reproductive system and breast disorders None View
Impaired Coordination None Nervous system disorders None View
Fatigue None Nervous system disorders None View
Nervousness None Nervous system disorders None View
Insomnia None Nervous system disorders None View
Tremor None Nervous system disorders None View
Weight Gain None Gastrointestinal disorders None View
Weight Loss None Gastrointestinal disorders None View
Dermatitis None Skin and subcutaneous tissue disorders None View
Urinary Dysfunction None Renal and urinary disorders None View
Changes in breasts None Reproductive system and breast disorders None View
Increased thirst None Gastrointestinal disorders None View
Somnolence None Nervous system disorders None View
Extrapyramidal symptoms None Nervous system disorders None View