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 @ 5:09 PM
Ignite Modification Date: 2025-12-25 @ 2:47 PM
NCT ID: NCT00395850
Description: although participants were out of the protocol at the end of week 14, because disulfiram could interact with alcohol for up to 2 weeks after stopping use, we continued to monitor participants during this time.
Frequency Threshold: 5
Time Frame: 12 weeks (during disulfiram phase) plus 2 wk washout
Study: NCT00395850
Study Brief: Disulfiram for Cocaine Abuse
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 microcrystalline cellulose None None 1 20 8 20 View
Disulfiram 250 disulfiram at 250 mg/day None None 1 23 12 23 View
Disulfiram 375 Disulfiram at 375 mg/day None None 1 24 10 24 View
Disulfiram 500 Disulfiram at 500 mg/day None None 0 21 11 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute COPD exacerbation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Spinal Abcess SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
GI Distress (e.g., nausea, vomiting, etc.) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Slurred speech SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sweating SYSTEMATIC_ASSESSMENT General disorders None View
Increased Vital Signs (e.g., BP, HR) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Metallic or Garlic Taste SYSTEMATIC_ASSESSMENT General disorders None View
Dry mouth/Excessive Thirst SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lethargy/Sedation SYSTEMATIC_ASSESSMENT General disorders None View
Anxiety/Nervousness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View