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 @ 12:45 AM
Ignite Modification Date: 2025-12-25 @ 10:58 PM
NCT ID: NCT04328467
Description: None
Frequency Threshold: 5
Time Frame: up to 12 weeks
Study: NCT04328467
Study Brief: Pre-exposure Prophylaxis for SARS-Coronavirus-2
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention Once Weekly 400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral 0 None 3 494 0 494 View
Intervention Twice Weekly 400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral 0 None 6 495 0 495 View
Control Group Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks Placebo: Placebo; tablet; oral 0 None 8 494 0 494 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hysteroscopy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Elective Coronary Angiogram SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Motor Vehicle Accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sarcoidosis Biopsy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Diverticulitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Spinal Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Gall Bladder Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hyperthyroid SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Not Specified SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):