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 @ 9:34 PM
Ignite Modification Date: 2025-12-25 @ 7:18 PM
NCT ID: NCT04336332
Description: None
Frequency Threshold: 5
Time Frame: The period of time over which adverse event data was collected is after six days.
Study: NCT04336332
Study Brief: Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 1: Hydroxychloroquine Sulfate + Azithromycin * Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days * Azithromycin 500 mg taken by mouth on Day 1, followed by * Azithromycin 250 mg taken by mouth once (1) time a day for four (4) days. Hydroxychloroquine Sulfate + Azithromycin: Given PO Hydroxychloroquine Sulfate: Given PO 4 None 0 16 7 16 View
Arm 2: Hydroxychloroquine Sulfate Alone • Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days Hydroxychloroquine Sulfate: Given PO 4 None 1 30 13 30 View
Arm 3: Placebo * Placebo pills Days 1-6. * If you still have COVID-19 symptoms you will receive Hydroxychloroquine sulfate 200 mg by mouth three (3) times a day for 10 days 1 None 1 29 5 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Respiratory, thoracic and mediastinal disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Investigations SYSTEMATIC_ASSESSMENT Investigations None View
Infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blood and lymphatic system disorders SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Metabolism and nutrition disorders SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View