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 @ 9:18 PM
Ignite Modification Date: 2025-12-25 @ 7:06 PM
NCT ID: NCT02328404
Description: Vitamin D supplementation for vitamin D deficient (\<20 ng/ml) women with 50,000 IU/week for 12 weeks did not lead to any side effects.
Frequency Threshold: 0
Time Frame: Baseline, 3 months
Study: NCT02328404
Study Brief: The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome (PCOS)
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 (Biodal 50,000IU) 50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route 50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months None None 0 30 1 30 View
Placebo placebo coated tablet by oral route placebo: placebo coated tablet by oral route None None 0 30 1 30 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
In-compliance , Withdral NON_SYSTEMATIC_ASSESSMENT Social circumstances None View