Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:21 AM
Ignite Modification Date: 2025-12-26 @ 12:52 AM
NCT ID: NCT00703534
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00703534
Study Brief: Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AZD3355 AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed None None 1 None 18 None View
Placebo Placebo capsules twice daily, Gelusil tablets as rescue medication if needed None None 2 None 7 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Operative Hemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Suicide Attemp NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Pulmonary Oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Respiratory Failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View