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 @ 5:36 PM
Ignite Modification Date: 2025-12-25 @ 3:07 PM
NCT ID: NCT04358068
Description: Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
Frequency Threshold: 0
Time Frame: From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Study: NCT04358068
Study Brief: Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With 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 A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro) Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS: Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days). Hydroxychloroquine (HCQ): Administered orally Azithromycin (Azithro): Administered orally 0 None 0 9 2 9 View
Arm B: Placebo for Hydroxychloroquine and Azithromycin Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS: Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days). Placebo for Hydroxychloroquine: Administered orally Placebo for Azithromycin: Administered orally 0 None 1 11 3 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Ageusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Anosmia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Nasal obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View