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 @ 2:55 AM
Ignite Modification Date: 2025-12-26 @ 1:36 AM
NCT ID: NCT00302133
Description: None
Frequency Threshold: 0
Time Frame: Adverse events reported by subjects during their participation in the study
Study: NCT00302133
Study Brief: Optimizing Pharmacotherapy for Bipolar Alcoholics
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo add on to valproate open label Placebo add on to open label valproate for 12 weeks None None 0 9 5 9 View
Naltrexone Naltrexone add on to valproate open label naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate None None 0 9 5 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Palpitation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Nausea/ diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Abdominal cramps SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.0 View
Accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View