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 @ 4:08 AM
Ignite Modification Date: 2025-12-26 @ 3:05 AM
NCT ID: NCT00880620
Description: None
Frequency Threshold: 5
Time Frame: 1 year, 6 months
Study: NCT00880620
Study Brief: A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With 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
Placebo Placebo capsules were used None None 3 92 26 92 View
IPX066 145 mg LD IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa None None 4 87 27 87 View
IPX066 245 mg LD IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa None None 5 104 47 104 View
IPX066 390 mg LD IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa None None 2 98 48 98 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (12.0) View
Atrioventricular block complete NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (12.0) View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (12.0) View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (12.0) View
Abdominal strangulated hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
Escherichia urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (12.0) View
Non-Hodgkin's Lymphoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (12.0) View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.0) View
Emphysema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.0) View
Coronary Artery Bypass NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (12.0) View
Prostatectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (12.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyskinesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (12.0) View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (12.0) View
Orthostatic Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (12.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (12.0) View
Abnormal dreams NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (12.0) View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View