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 @ 3:00 PM
Ignite Modification Date: 2025-12-25 @ 1:24 PM
NCT ID: NCT01174459
Description: Number of participants at risk is based on safety set.
Frequency Threshold: 5
Time Frame: During the 12-month period or within 2 days after the last administration of pramipexole, up to 990 days.
Study: NCT01174459
Study Brief: Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Patient With Restless Legs Syndrome Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day None None 10 510 0 510 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 16.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 16.1 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 16.1 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 16.1 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MEDDRA 16.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 16.1 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 16.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA 16.1 View
Metastases to meninges SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 16.1 View
Metastases to central nervous system SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 16.1 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 16.1 View
Impulse-control disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDDRA 16.1 View
Somatic hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDDRA 16.1 View
Other Events(If Any):