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 @ 7:15 PM
Ignite Modification Date: 2025-12-25 @ 4:52 PM
NCT ID: NCT00474903
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00474903
Study Brief: Esomeprazole Magnesium With or Without Aspirin in Preventing Esophageal Cancer in Patients With Barrett Esophagus
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 I (Placebo, Esomeprazole Magnesium) Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily). esomeprazole magnesium: Given orally placebo: Given orally None None 0 30 8 30 View
Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium) Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily). acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally None None 0 45 9 45 View
Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium) Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily). acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally None None 1 45 15 45 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 9 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Colonic hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Esophageal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Flu-like symptoms SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 9 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Muscle weakness upper limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Musculoskeletal disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Hemorrhage nasal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View