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 @ 5:11 AM
Ignite Modification Date: 2025-12-26 @ 4:16 AM
NCT ID: NCT00368927
Description: CTCAE Version 3.0
Frequency Threshold: 0
Time Frame: Month 1 to ≤30 days after the end of intervention
Study: NCT00368927
Study Brief: Sulindac in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm A (Sulindac) Patients receive oral sulindac twice daily for 6 months. None None 2 31 25 31 View
Arm B (Placebo) Patients receive oral placebo twice daily for 6 months. None None 0 30 24 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Middle ear inflammation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 9 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Dry eye syndrome SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Lower gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Flu-like symptoms SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
General symptom SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Intraoperative musculoskeletal injury - Joint SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Extrapyramidal disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Neurological disorder NOS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Reproductive tract disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pulmonary hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Respiratory tract hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View