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 @ 10:52 PM
Ignite Modification Date: 2025-12-25 @ 8:21 PM
NCT ID: NCT01456169
Description: The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
Frequency Threshold: 2
Time Frame: For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
Study: NCT01456169
Study Brief: A Study to Evaluate the Effectiveness and Safety of a Fixed Dose Combination of Azilsartan Medoxomil and Chlorthalidone in Patients With High Blood Pressure Who do Not Achieve Target Blood Pressure Following Treatment With Azilsartan Medoxomil Alone
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Azilsartan Medoxomil 40 mg Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period. None None 2 133 15 133 View
Azilsartan Medoxomil + Chlorthalidone 40/25 mg Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period. None None 0 135 26 135 View
Monotherapy: Azilsartan Medoxomil 40 mg Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for 4 weeks during the Single-Blind Monotherapy Treatment Period. All enrolled participants, including those who were not randomized to double-blind treatment are included in this group. None None 3 507 15 507 View
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period. None None 0 127 13 127 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 15.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 15.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 15.1 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 15.1 View
Renal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 15.1 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 15.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 15.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 15.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 15.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 15.1 View