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: 2025-12-26 @ 11:09 AM
Ignite Modification Date: 2025-12-26 @ 11:09 AM
NCT ID: NCT02353312
Description: There were 28 patients enrolled.
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT02353312
Study Brief: Rhode Island Diastolic Dysfunction - Heart Failure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
On Kuvan Kuvan® supplementation in addition to standard care for heart failure for three months. At the end of three months, stop Kuvan®, patients will only receive Standard care for heart failure for another 3 months Kuvan: Kuvan® (sapropterin dihydrochloride) will be initiated at 10mg/kg/day with meals for one week. After telephone contact on day 7, assuming no adverse effects are noted, the patient will be instructed to increase their daily dose to 20mg/kg/day with meals for the remainder of the 3 months. 0 None 4 28 28 28 View
Off Kuvan Standard care for heart failure for three months. At the end of three months, Starting Kuvan® supplementation in addition to Standard care for heart failure for another 3 months 0 None 6 28 28 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalizations NON_SYSTEMATIC_ASSESSMENT Investigations None View
ER visit NON_SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Emesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rhinorrhea NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
weight gain NON_SYSTEMATIC_ASSESSMENT General disorders None View
JVD NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pulmonary crackles NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Peripheral abdominal edema NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View