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 @ 12:05 AM
Ignite Modification Date: 2025-12-25 @ 10:03 PM
NCT ID: NCT04701658
Description: All participants who received single dose of Bamlanivimab.
Frequency Threshold: 0
Time Frame: Baseline through Follow-up (Up to 90 days)
Study: NCT04701658
Study Brief: A Real World Study of Bamlanivimab in Participants With Mild-to-Moderate Coronavirus Disease 2019 (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
Bamlanivimab 700 mg Participants received 700 mg single IV infusion of Bamlanivimab. 0 None 2 109 9 109 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
End stage renal disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Infusion site extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Paranasal sinus hypersecretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pharyngeal swelling SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View