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 @ 10:03 PM
Ignite Modification Date: 2025-12-25 @ 7:39 PM
NCT ID: NCT03521635
Description: Treated set (TS) was defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.
Frequency Threshold: 5
Time Frame: From randomisation through end of treatment until end of follow up visit, up to 18 weeks + 2 days.
Study: NCT03521635
Study Brief: The SUSTAIN Study Compares the Effects of Sustained and Immediate-release Pramipexole on the noctUrnal Symptoms of paTients With Advanced ParkInsoN's Disease Who Also Take L-Dopa
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pramipexole Sustained Release Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects. 0 None 0 49 4 49 View
Pramipexole Immediate Release Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks. The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects. 0 None 1 49 7 49 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Mechanical ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.1 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View