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 @ 4:03 PM
Ignite Modification Date: 2025-12-25 @ 2:05 PM
NCT ID: NCT02517866
Description: At each visit the investigator had to document 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 the relation to study treatment. Adverse Events are reported as per dose received.
Frequency Threshold: 5
Time Frame: From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
Study: NCT02517866
Study Brief: Azilsartan Medoxomil in the Treatment of Essential Hypertension and Type 2 Diabetes in Asia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Before Week 6 Azilsartan Medoxomil 40 mg Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 6 weeks. None None 4 380 0 380 View
After Week 6 Azilsartan Medoxomil 40 mg Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for Week 6 up to Week 12. None None 3 258 0 258 View
After Week 6 Azilsartan Medoxomil 80 mg Azilsartan medoxomil 80 mg, tablets, orally, once, daily, for Week 6 up to Week 12. None None 1 97 0 97 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 19.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 19.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 19.0 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 19.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 19.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 19.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 19.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 19.0 View
Other Events(If Any):