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 @ 11:08 PM
Ignite Modification Date: 2025-12-25 @ 8:41 PM
NCT ID: NCT01496469
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.
Frequency Threshold: 2
Time Frame: Treatment-emergent AEs are defined as any AEs, regardless of relationship to study drug, which occurs on or after the first double-blind dose date and up to 30 days after the last dose date of the double-blind study drug.
Study: NCT01496469
Study Brief: Effect of Febuxostat on Blood Pressure
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 Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks. None None 1 60 1 60 View
Febuxostat 80 mg Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week. None None 1 61 3 61 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary artery insufficiency SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (15.0) View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (15.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (15.0) View