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 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
NCT ID:
NCT00485069
Description:
None
Frequency Threshold:
5
Time Frame:
From Baseline (Week 0) through the end of follow-up (up to Week 56).
Study:
NCT00485069
Study Brief:
REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| ROP+L-Dopa | Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study. | None | None | 7 | 65 | 42 | 65 | View |
| Ropinirole Hydrochloride | Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study. | None | None | 3 | 58 | 43 | 58 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| Parkinson's Disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Sudden onset of sleep | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 12.1 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Gastric cancer recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| Meniscus lesion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Parkinson's Disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Sudden onset of sleep | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Dyskinesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |