Comparison · NCT01536574-sae
Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study vs Placebo in Parent DB Study, Ropinirole PR in OL Study: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study vs Placebo in Parent DB Study, Ropinirole PR in OL Study: serious adverse events. Trial comparisons, record NCT01536574-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01536574-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0123 | 0.00339 | 0.0439 | wilson | |
| Risk in group 2 | 0.0301 | 0.0118 | 0.0748 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0177 | -0.0633 | 0.0187 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.41 | 0.0764 | 2.21 | log | |
| Odds ratio, group 1 over group 2 | 0.403 | 0.0727 | 2.24 | log | |
Number needed to treat, for one fewer participant with a serious adverse event on Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study than on Placebo in Parent DB Study, Ropinirole PR in OL Study | 56.4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR. | 2 | 162 | EG000 |
| Group 2 | Placebo in Parent DB Study, Ropinirole PR in OL Study | Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR. | 4 | 133 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- AEs and SAEs are presented for the On-treatment Phase, including the Open-label Treatment Phase (24 weeks) and the Down-titration Phase (1 week) (up to Study Week 25).
Source ClinicalTrials.gov
Trial
- Title
- Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528
- NCT number
- NCT01536574
- Phases
- PHASE3
- Conditions
- Parkinson Disease
- Interventions
- Requip PR
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2012-12-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01536574?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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