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: 2025-12-25 @ 12:39 AM
Ignite Modification Date: 2025-12-25 @ 10:50 PM
NCT ID: NCT00843167
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00843167
Study Brief: Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sulforaphane Supplement Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity. broccoli sprout extract: Given orally None None 0 27 8 27 View
Placebo Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity. placebo: Given orally None None 0 27 9 27 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gas/Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea/Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Taste Alteration SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Bruising SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Feeling tired SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
More sleep SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sleeping less SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Allergy SYSTEMATIC_ASSESSMENT Immune system disorders None View
Cramping SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shoulder pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tingling tongue sensation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Arthritic pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View