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 @ 1:13 AM
Ignite Modification Date: 2025-12-25 @ 11:23 PM
NCT ID: NCT00251693
Description: None
Frequency Threshold: 4
Time Frame: None
Study: NCT00251693
Study Brief: Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of 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
Dexlansoprazole MR 60 mg QD Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks. None None 5 680 63 680 View
Dexlansoprazole MR 90 mg QD Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks. None None 2 668 53 668 View
Lansoprazole 30 mg QD Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. None None 6 690 50 690 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 View
Duodenal and Small Intestinal Stenosis and Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Gastrointestinal (GI) Atonic and Hypomotility Disorders NEC SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal Inflammatory Disorders NEC SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haemorrhoids and GI Varices (Excluding [Excl] Oesophageal) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal Ulcers and Perforation NEC SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Peritoneal and Retroperitoneal Disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pain and Discomfort NEC SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cholecystitis and Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Infections NEC SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower Respiratory Tract and Lung Infections SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sepsis, Bacteraemia, Viraemia and Fungaemia NEC SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Streptococcal Infections SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Non-site Specfic Procedural Complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Potassium Imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Soft Tissue Disorders NEC SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Acute Polyneuropathies SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Transient Cerebrovascular (CV) Events SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paralysis and Paresis (Excl Cranial Nerve) SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Central Nervous System Hemorrhages and CV accidents SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Bipolar Disorders SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Respiratory Failures (Excl Neonatal) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea (Excl Infective) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal and Abdominal Pains (Excl Oral and Throat) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Upper Respiratory Tract Infections SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View