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 @ 12:27 AM
Ignite Modification Date: 2025-12-25 @ 10:32 PM
NCT ID: NCT02226367
Description: This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.
Frequency Threshold: 0
Time Frame: Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks.
Study: NCT02226367
Study Brief: Prazosin Augmentation of Outpatient Treatment of Alcohol Use Disorders in Active Duty Soldiers With and Without PTSD
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. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment. placebo: study drug arm placebo 0 None 1 56 52 56 View
Prazosin Hydrochloride Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects. prazosin hydrochloride: study drug arm prazosin 0 None 2 46 44 46 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
skull fracture and subdural hematoma NON_SYSTEMATIC_ASSESSMENT General disorders None View
Suicidal Ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
anxiety associated with occupational stressors NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
dizziness on standing SYSTEMATIC_ASSESSMENT General disorders None View
Nasal Congestion SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lightheadedness SYSTEMATIC_ASSESSMENT General disorders None View
Weakness SYSTEMATIC_ASSESSMENT General disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Peripheral edema SYSTEMATIC_ASSESSMENT General disorders None View
Depressed Mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View