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: 2025-12-24 @ 4:56 PM
Ignite Modification Date: 2025-12-25 @ 2:38 PM
NCT ID: NCT01191450
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT01191450
Study Brief: Safety and Efficacy of Chlorthalidone + Amiloride to Elderly Patients Treatment With Arterial Hypertension
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Higroton® Chlorthalidone 25mg - one oral tablet a day in the morning Higroton® Laboratório Novartis: Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks None None 1 121 41 121 View
Diupress® Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning Chlorthalidone 25 mg + amiloride hydrochloride 5 mg: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks None None 2 122 55 122 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial ischaemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders Myocardial ischaemia View
Abdominal pain NOS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Innappetence SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Musculoskeletal and Connective Tissue Disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
General Disorders and Administration Site Conditions SYSTEMATIC_ASSESSMENT General disorders None View
Metabolism and Nutrition Disorders SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Investigations SYSTEMATIC_ASSESSMENT Investigations None View
Nervous System Disorders SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Renal and Urinary Disorders SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Reproductive System and Breast Disorders SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Immune System Disorders SYSTEMATIC_ASSESSMENT Immune system disorders None View
Vascular Disorders SYSTEMATIC_ASSESSMENT Vascular disorders None View
Gastrointestinal Disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View