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 @ 12:31 AM
Ignite Modification Date: 2025-12-25 @ 10:38 PM
NCT ID: NCT03068767
Description: Death: 0% Serious adverse event: 0% adverse event: 6%
Frequency Threshold: 0
Time Frame: 2 months
Study: NCT03068767
Study Brief: The Relationship Between Vitamin D and Hepatitis B Virus Replication
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 D Group Patients receiving vitamin D supplement (2000 IU/day) for 2 months Vitamin D No serious adverse events noted. 0 None 0 75 3 75 View
Control Group Patients without receiving vitamin D supplement No serious adverse events noted. 0 None 0 74 6 74 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
tearing SYSTEMATIC_ASSESSMENT Eye disorders None View
urine occult blood positive NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
skin rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
sneezing NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
acid reflux NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
leg soreness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View