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: 2025-12-26 @ 10:57 AM
Ignite Modification Date: 2025-12-26 @ 10:57 AM
NCT ID: NCT00464308
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00464308
Study Brief: A Study to Compare the Number of Patients With Gastro-Oesophageal Reflux Disease (GORD) Achieving Heartburn and Regurgitation Symptom Resolution After Treatment With Either Rabeprazole Sodium 20mg, Esomeprazole 20mg or Esomeprazole 40mg
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rabeprazole 20 mg/Day Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily None None 5 464 151 464 View
Esomeprazole 40 mg/Day Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily None None 1 469 155 469 View
Esomeprazole 20 mg/Day Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily None None 9 459 158 459 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
meniscal tear of right knee NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.0 View
lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
alleged assault NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 11.0 View
chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
angina unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
fever NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
perianal abscess drainage NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.0 View
urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
multiple pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Joint disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal and connective tissue disorders NEC SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headaches SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Neurological disorders NEC SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Infections - pathogen class unspecified SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infectious disorders SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Salivary gland conditions SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal motility and defaecation cond SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal signs and symptoms SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View