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 @ 11:41 PM
Ignite Modification Date: 2025-12-25 @ 9:32 PM
NCT ID: NCT01371851
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01371851
Study Brief: Doxazosin for Psychostimulant Dependence
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 Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial. Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial. None None 1 11 8 11 View
Placebo Participants will be maintained on placebo (cellulose) throughout the trial. Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial. None None 0 11 4 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Muscle Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Numbness in fingertips SYSTEMATIC_ASSESSMENT Nervous system disorders None View
black eye SYSTEMATIC_ASSESSMENT Eye disorders None View
palpitations with shortness of breath SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sweating SYSTEMATIC_ASSESSMENT General disorders None View
Head edema from fight SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sleep Disturbances SYSTEMATIC_ASSESSMENT General disorders None View
Elevated blood pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal pain and pain on urinating SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Orthostatic Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lightheadedness, dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
nausea, abdominal cramps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Drowsiness, Fatigue SYSTEMATIC_ASSESSMENT General disorders None View