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 @ 7:12 PM
Ignite Modification Date: 2025-12-25 @ 4:47 PM
NCT ID: NCT04868903
Description: None
Frequency Threshold: 0
Time Frame: Up to 9 months after randomization
Study: NCT04868903
Study Brief: Low vs. Moderate to High Dose Vitamin D for Prevention of 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
Low Dose Vitamin D (moderate versus low branch) Subjects in this arm will be randomized to receive low dose vitamin D therapy (oral, 400 IU/day) for up to 9 continuous months. 0 None 0 300 0 300 View
Moderate Dose Vitamin D Subjects in this arm will be randomized to receive low dose vitamin D therapy (oral, 4,000 IU/day) for up to 9 continuous months. 0 None 0 299 0 299 View
Low Dose Vitamin D (high versus low branch) Subjects in this arm will be randomized to receive low dose vitamin D therapy (oral, 400 IU/day) for up to 9 continuous months. 0 None 0 162 0 162 View
High Dose Vitamin D Subjects in this arm will be randomized to receive low dose vitamin D therapy (oral, 10,000 IU/day) for up to 9 continuous months. 0 None 0 162 1 162 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View