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 @ 10:12 PM
Ignite Modification Date: 2025-12-25 @ 7:47 PM
NCT ID: NCT00917735
Description: Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Frequency Threshold: 0
Time Frame: 5 years
Study: NCT00917735
Study Brief: Green Tea and Reduction of Breast Cancer Risk
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Green Tea Extract Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG. None None 12 538 407 538 View
Sugar Pill Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate. None None 8 537 391 537 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Elevated ALT or AST enzyme SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAE (4.0) View
Acoustic Neuroma SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.0) View
Diagnosis of Uterine Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (4.0) View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Motorcycle accident SYSTEMATIC_ASSESSMENT Social circumstances CTCAE (4.0) View
Hypertension SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Fall SYSTEMATIC_ASSESSMENT Social circumstances CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vascular SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Respitory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
General SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Musuclar SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Other SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Infections SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View