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 @ 3:32 PM
Ignite Modification Date: 2025-12-25 @ 1:46 PM
NCT ID: NCT00699192
Description: Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
Frequency Threshold: 5
Time Frame: 8 weeks
Study: NCT00699192
Study Brief: Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential 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
Amlodipine/Valsartan 5/80 mg 1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily None None 5 274 0 274 View
Amlodipine/Valsartan 5/40 mg 1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily None None 2 272 0 272 View
Amlodipine 5 mg 1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily None None 1 272 0 272 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tachyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Lentigo maligna stage unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Gastric cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Ophthalmoplegia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Other Events(If Any):