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 @ 9:16 PM
Ignite Modification Date: 2025-12-25 @ 7:05 PM
NCT ID: NCT00434304
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00434304
Study Brief: Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ropinirole PR/XR (Taper Phase) The dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal) None None 1 62 0 62 View
Ropinirole PR/XR (Treatment Phase) Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 mg as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. None None 5 62 51 62 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ovarian neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Small intestine carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anti-neutrophil cytoplasmic antibody positive vasculitis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Glomerulonephritis rapidly progressive SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomach discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Edema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View