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: 2025-12-25 @ 4:47 AM
Ignite Modification Date: 2025-12-26 @ 3:49 AM
NCT ID: NCT02231918
Description: None
Frequency Threshold: 5
Time Frame: From first drug administration until 24 hours after last study drug administration, upto 48 days
Study: NCT02231918
Study Brief: Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MIRAPEX® (0.125 mg) Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state. None None 0 9 2 9 View
MIRAPEX® (0.25 mg) Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state. None None 0 15 3 15 View
MIRAPEX® (0.5 mg) Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state. None None 0 2 1 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 10.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 10.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MEDDRA 10.1 View
Infusion site erythema SYSTEMATIC_ASSESSMENT General disorders MEDDRA 10.1 View
Infusion site irritation SYSTEMATIC_ASSESSMENT General disorders MEDDRA 10.1 View
Infusion site pain SYSTEMATIC_ASSESSMENT General disorders MEDDRA 10.1 View
Vessel puncture site erythema SYSTEMATIC_ASSESSMENT General disorders MEDDRA 10.1 View
Vessel puncture site pain SYSTEMATIC_ASSESSMENT General disorders MEDDRA 10.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA 10.1 View