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 @ 2:49 AM
Ignite Modification Date: 2025-12-26 @ 1:30 AM
NCT ID: NCT00402233
Description: None
Frequency Threshold: 5
Time Frame: 12 weeks
Study: NCT00402233
Study Brief: A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients
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 (Pramipexole 0.5 mg Tid) Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period. None None 1 80 43 80 View
Placebo matching tablet None None 0 77 27 77 View
Mirapex (Pramipexole 0.5 mg Bid) Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period. None None 0 81 42 81 View
Mirapex (Pramipexole 0.75 mg Bid) Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period. None None 2 73 37 73 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders MEDRA 12.0 View
Cerebral Infarction, Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MEDRA 12.0 View
ileus (patient stopped drugs 2 days prior) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MEDRA 12.0 View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MEDRA 12.0 View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MEDRA 12.0 View
tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MEDRA 12.0 View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA 12.0 View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA 12.0 View
insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDRA 12.0 View
abnormal dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDRA 12.0 View
fatigue SYSTEMATIC_ASSESSMENT General disorders MEDRA 12.0 View
oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MEDRA 12.0 View