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 @ 12:28 AM
Ignite Modification Date: 2025-12-25 @ 10:34 PM
NCT ID: NCT00558467
Description: None
Frequency Threshold: 5
Time Frame: All events with an onset after the first dose of study medication and up to a period of 48 hours after the last dose of study medication were assigned to the treatment period.
Study: NCT00558467
Study Brief: Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo tablets matching the Pramipexole tablets to be taken per os None None 1 20 13 20 View
Pramipexole Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. None None 0 43 25 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Tic SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View