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 @ 3:37 AM
Ignite Modification Date: 2025-12-26 @ 2:21 AM
NCT ID: NCT02500602
Description: Participants were asked about any changes in health or existing symptoms at each visit.
Frequency Threshold: 5
Time Frame: AEs collected from baseline (if baseline lasted longer than one appointment) through follow up (12 week treatment phase and 6 week follow up - approximately 20 weeks)
Study: NCT02500602
Study Brief: CAP: Doxazosin in the Treatment of Co-Occurring PTSD and Alcohol Use Disorders
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Doxazosin Participants randomly assigned to receive doxazosin (target dose of 16 mg/day). doxazosin: active medication 0 None 12 74 48 74 View
Placebo Participants randomly assigned to receive Placebo pill placebo: placebo pill 0 None 9 70 40 70 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dehydration SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hernia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Suicidal Ideation/Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Anger/Frustration SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Homicidal Ideation/Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Substance Use SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Panic Attack/Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Diabetes Complications SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Generalized Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Accident/Injury SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Joint/Muscle Pain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Drowsiness/Grogginess SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sleep Problems SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Emotional Distress SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Stomach Virus/Cramping/Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Cold/Sinus/Congestion SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Dizziness/Lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Vivid Dreams/Nightmares SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View