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 @ 2:22 AM
Ignite Modification Date: 2025-12-26 @ 12:54 AM
NCT ID: NCT00921934
Description: None
Frequency Threshold: 1
Time Frame: 1.5 years
Study: NCT00921934
Study Brief: Intravenous Vitamin C in the Treatment of Viral Infection, Especially in the Treatment of Shingles
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 C Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C. None None 0 68 2 68 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sensation of heat on the injection site SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.0) View
numbness sensation up to the fingertips SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.0) View
burning SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.0) View
Urticarial drug inducted exanthema on truncus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (14.0) View
Urticarial drug inducted exanthema on torso SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (14.0) View
protracted diarrhoe SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.0) View