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 @ 12:36 AM
Ignite Modification Date: 2025-12-25 @ 10:44 PM
NCT ID: NCT00434967
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT00434967
Study Brief: Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose) None None 2 None 0 None View
Candesartan 32 mg candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes) None None 6 None 38 None View
HCT 25 mg HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose) None None 2 None 22 None View
Candesartan/HCT 32/25 mg candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes) None None 1 None 23 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Electrocardiogram Abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Major Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Acute Coronary Syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Cardiac Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Lower Limb Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Sudden Death SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View