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 @ 11:43 PM
Ignite Modification Date: 2025-12-25 @ 9:35 PM
NCT ID: NCT00255151
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00255151
Study Brief: Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo QD Placebo capsules, orally, once daily for up to 6 months. None None 0 None 7 None View
Dexlansoprazole MR 60 mg QD Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months. None None 2 None 33 None View
Dexlansoprazole MR 90 mg QD Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months. None None 5 None 25 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary Artery Disorders Not Elsewhere Classified (NEC) SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9.1 View
Acute and Chronic Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.1 View
Pain and Discomfort NEC SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.1 View
Non-site Specific Injuries NEC SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9.1 View
Musculoskeletal and Connective Tissue Signs and Symptoms NEC SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9.1 View
Breast and Nipple Neoplasms Malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 9.1 View
Uterine Disorders NEC SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea (Excluding [Excl] Infective) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.1 View
Flatulence, Bloating and Distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.1 View
Gastritis (Excl Infective) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.1 View
Gastrointestinal and Abdominal Pains (Excl Oral and Throat) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.1 View
Upper Respiratory Tract Infections SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.1 View