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 @ 11:51 AM
Ignite Modification Date: 2025-12-25 @ 11:53 AM
NCT ID: NCT04328961
Description: Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.
Frequency Threshold: 0
Time Frame: Adverse event data was collected during the period of follow up, which was 28 days.
Study: NCT04328961
Study Brief: Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Hydroxychloroquine Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy 0 None 2 407 66 407 View
Ascorbic Acid Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy. 0 None 2 422 46 422 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalizations NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Allergic Reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin reaction/rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Taste change or dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Diarrhea, abdominal discomfort, or vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea or upset stomach NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neurologic reaction: irritability, dizziness, or vertifgo NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hot flashes, night sweats, or palpitations NON_SYSTEMATIC_ASSESSMENT General disorders None View
Visual Changes NON_SYSTEMATIC_ASSESSMENT Eye disorders None View