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 @ 12:00 AM
Ignite Modification Date: 2025-12-25 @ 9:58 PM
NCT ID: NCT02162758
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold: 0
Time Frame: Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13).
Study: NCT02162758
Study Brief: Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett's Esophagus With Radiofrequency Ablation
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 60 mg QD Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months. None None 1 3 2 3 View
Dexlansoprazole 60 mg BID Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months. None None 2 3 2 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (19.0) View
Aspiration pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View
Worsening of back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (19.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (19.0) View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (19.0) View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View