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 @ 7:00 PM
Ignite Modification Date: 2025-12-25 @ 4:33 PM
NCT ID: NCT01292057
Description: Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
Frequency Threshold: 5
Time Frame: 8 days
Study: NCT01292057
Study Brief: Aripiprazole Effects on Alcohol Drinking and Craving
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Aripiprazole Medication Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days None None 0 47 39 47 View
Sugar Pill Placebo: Placebo to match active drug Aripiprazole for 8 days None None 0 48 17 48 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Trouble sleeping SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Daytime sleepiness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nervousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Irritability SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Trouble concentrating SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Feeling depressed SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Low energy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Increased libido SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Decreased libido SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View