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: 2025-12-24 @ 9:16 PM
Ignite Modification Date: 2025-12-25 @ 7:05 PM
NCT ID: NCT01599104
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT01599104
Study Brief: Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients 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
LCZ696 200 mg LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks None None 1 387 48 387 View
LCZ696 400 mg LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks None None 1 385 47 385 View
Olmesartan 20 mg Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks None None 7 389 46 389 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ARTERIOSCLEROSIS CORONARY ARTERY SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
SUPRAVENTRICULAR TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
HEPATOBILIARY DISEASE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
RADIUS FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
CATARACT SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
BILE DUCT STONE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
OSTEOARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
CEREBRAL INFARCTION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
SUBARACHNOID HAEMORRHAGE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View