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 @ 9:26 PM
Ignite Modification Date:
2025-12-25 @ 7:11 PM
NCT ID:
NCT01494532
Description:
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
Frequency Threshold:
5
Time Frame:
Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
Study:
NCT01494532
Study Brief:
A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced 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 |
|---|---|---|---|---|---|---|---|---|
| Treatment Group A: Placebo | Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication. | None | None | 0 | 75 | 31 | 75 | View |
| Treatment Group B: 4 mg/Day | Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication. | None | None | 0 | 25 | 9 | 25 | View |
| Treatment Group C: 8 mg/Day | Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication. | None | None | 3 | 76 | 27 | 76 | View |
| Treatment Group D: 12 mg/Day | Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication. | None | None | 0 | 75 | 40 | 75 | View |
| Treatment Group E: 16 mg/Day | Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication. | None | None | 1 | 76 | 43 | 76 | View |
| Treatment Group F: 24 mg/Day | Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication. | None | None | 0 | 25 | 11 | 25 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v 18.0 | View |
| Adenocarcinoma gastric | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 18.0 | View |
| Impulsive behaviour | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v 18.0 | View |
| Hernia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v 18.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v 18.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v 18.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v 18.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v 18.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v 18.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v 18.0 | View |
| Dyskinesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v 18.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v 18.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v 18.0 | View |
| Sudden onset of sleep | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v 18.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v 18.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v 18.0 | View |