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: 2025-12-26 @ 11:07 AM
Ignite Modification Date: 2025-12-26 @ 11:07 AM
NCT ID: NCT00951912
Description: None
Frequency Threshold: 0
Time Frame: We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.
Study: NCT00951912
Study Brief: The Effects of Soy Isoflavones to Improve the Metabolism of Glucose and Lipids
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo the placebo group were given 10g soy protein isolated without isoflavones None None 0 54 4 54 View
Daidzein Daidzein group were given 10g soy protein isolated and 50mg purify daidzein None None 0 55 4 55 View
Genistein Genistein group were given 10g soy protein isolated and 50mg purify genistein None None 0 56 2 56 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
vignal bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
hyperplasia of mammary glands NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
thirsty NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View