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 @ 7:02 PM
Ignite Modification Date: 2025-12-25 @ 4:36 PM
NCT ID: NCT02881957
Description: Catalog of CTCAE grade 3 or 4 adverse events directly related to study drug. Only adverse events or severe adverse events, related specifically to the study drug, were monitored. No serious events in any organ system were identified in this study and thus the listing of only the main heading for Serious Adverse Events and Other (Not Including Serious) Adverse Events reflects this, which is accurate and appropriate.
Frequency Threshold: 0
Time Frame: Adverse events were monitored until patient discharge from the hospital.
Study: NCT02881957
Study Brief: Hypovitaminosis D in Neurocritical Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vitamin D3 Patient demographics of patients receiving study drug 11 None 0 134 0 134 View
Placebo Patient demographics of patients receiving placebo 13 None 0 133 0 133 View
Serious Events(If Any):
Other Events(If Any):