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 @ 1:20 PM
Ignite Modification Date: 2025-12-25 @ 12:26 PM
NCT ID: NCT02925195
Description: None
Frequency Threshold: 0
Time Frame: 16 weeks
Study: NCT02925195
Study Brief: Individualized Response to Vitamin D Treatment Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Treatment Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily 1 None 2 499 55 499 View
Placebo Placebo 0 None 2 167 16 167 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diverticulosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Kidney stone SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiac disorders SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General disorders and administration site conditions SYSTEMATIC_ASSESSMENT General disorders None View
Immune system disorders SYSTEMATIC_ASSESSMENT Immune system disorders None View
Metabolism and nutrition disorders SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Musculoskeletal, connective tissue, and bone disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neoplasms benign, malignant, and unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Psychiatric disorders SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Renal and urinary tract disorders SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory, thoracic, and mediastinal disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
None SYSTEMATIC_ASSESSMENT General disorders None View