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 @ 2:06 PM
Ignite Modification Date: 2025-12-25 @ 12:48 PM
NCT ID: NCT00299195
Description: None
Frequency Threshold: 0
Time Frame: 2 years
Study: NCT00299195
Study Brief: A Randomized Study of Sulindac in Oral Premalignant Lesions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1 sulindac sulindac: Sulindac 150 mg po bid x 24 weeks 1 None 2 30 13 30 View
Cohort 2 placebo Placebo: Placebo bid x 24 weeks 4 None 4 33 13 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastrointestinal, other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dermatology/Skin, other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Death not assoc w CTCAE term- Death NOS SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain - Back SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain - Head/headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain - Joint SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain - Other (specify) SYSTEMATIC_ASSESSMENT General disorders None View
Pulm/upp respiratory - Other (spec) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sweating (diaphoresis) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dermatology/Skin, other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Gastritis (incl bile reflux gastritis) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hair loss/alopecia (scalp or body) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hemorrhage/Bleeding, other SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Inf norm ANC/gr1/2 neut-Bronchitis NOS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Inf norm ANC/gr1/2 neut-Gingivitis(oral-gums) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lymphatics - Other (specify) SYSTEMATIC_ASSESSMENT Immune system disorders None View
Mucositis (Clin exam)- Oral cavity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ocular/Visual - Other (specify) SYSTEMATIC_ASSESSMENT Eye disorders None View
Pain - Abdomen NOS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Endocrine, other SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Pain - Oral cavity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View