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 @ 9:08 PM
Ignite Modification Date: 2025-12-25 @ 6:59 PM
NCT ID: NCT00841204
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00841204
Study Brief: Sulindac in Preventing Melanoma in Healthy Participants Who Are at Increased Risk of Melanoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sulindac Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity. None None 1 25 22 25 View
Placebo Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity. None None 0 25 23 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vasovagal episode None Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation None Gastrointestinal disorders None View
Extremity/Limb pain None Musculoskeletal and connective tissue disorders None View
Larynx/Pharynx/Throat pain None Respiratory, thoracic and mediastinal disorders None View
Insomnia None Psychiatric disorders None View
Uterus pain None Reproductive system and breast disorders None View
Nausea None Gastrointestinal disorders None View
Prutitus None Skin and subcutaneous tissue disorders None View
Fatigue None General disorders None View
Other skin disorders None Skin and subcutaneous tissue disorders None View
Oral pain None Gastrointestinal disorders None View
Fever None General disorders None View
Stomach pain None Gastrointestinal disorders None View
Allergic reaction None Immune system disorders None View
Sinus infection None Infections and infestations None View
Urinary tract infection None Infections and infestations None View
Other infection None Infections and infestations None View
Bone pain None Musculoskeletal and connective tissue disorders None View
Headache None Nervous system disorders None View
Flu-like syndromes None General disorders None View
Other pain None General disorders None View
Muscle pain None Musculoskeletal and connective tissue disorders None View
Nasal/Paranasal congestion None Respiratory, thoracic and mediastinal disorders None View
Skin pain None Skin and subcutaneous tissue disorders None View
Diarrhea None Gastrointestinal disorders None View
Flatulence None Gastrointestinal disorders None View
Heartburn None Gastrointestinal disorders None View