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 @ 4:43 PM
Ignite Modification Date: 2025-12-25 @ 2:31 PM
NCT ID: NCT01280266
Description: As a cross over trial, study participants received both amlodipine and udenafil following each other.
Frequency Threshold: 1
Time Frame: During 8 weeks while taking a study drug.
Study: NCT01280266
Study Brief: Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Amlodipine Adverse effects observed while taking amlodipine in both study arms None None 0 26 14 26 View
Udenafil Adverse effects observed while taking udenafil in both study arms None None 2 26 19 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Facial edema SYSTEMATIC_ASSESSMENT General disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Facial flushing SYSTEMATIC_ASSESSMENT General disorders None View
Facial edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Peripheral edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Throat irritation NON_SYSTEMATIC_ASSESSMENT General disorders None View
Zoster NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View