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 @ 5:08 PM
Ignite Modification Date: 2025-12-25 @ 2:46 PM
NCT ID: NCT00076050
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00076050
Study Brief: Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Soy Isoflavones A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning. None None 9 122 121 122 View
Placebo A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning. None None 3 126 122 126 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
leukemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
breast cancer SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
abdominal bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
hair loss SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
breast tenderness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
edema of lower exteremity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
vaginal bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abnormal mammogram SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
joint tenderness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
tenderness lower extremities SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
upper respiratory track infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
urinary track infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View