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 @ 2:03 AM
Ignite Modification Date: 2025-12-26 @ 12:27 AM
NCT ID: NCT01968460
Description: None
Frequency Threshold: 5
Time Frame: 14 weeks
Study: NCT01968460
Study Brief: Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
P2B001 Treatment A Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily. P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily 0 None 1 49 37 49 View
P2B001 Treatment B Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily 0 None 0 50 20 50 View
Placebo Placebo once daily for 12 weeks. Placebo: placebo 0 None 0 50 24 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ACUTE MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (16.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.1) View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.1) View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.1) View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.1) View
nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.1) View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.1) View
tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.1) View
insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (16.1) View
orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (16.1) View