Comparison · NCT00823836-sae
Ropinirole PR-Ropinirole PR vs Ropinirole IR-Ropinirole PR: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Ropinirole PR-Ropinirole PR vs Ropinirole IR-Ropinirole PR: serious adverse events. Trial comparisons, record NCT00823836-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00823836-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 | 0.103 | 0.0641 | 0.16 | wilson | |
| Risk in group 2 | 0.11 | 0.0686 | 0.171 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00702 | -0.0791 | 0.0636 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.936 | 0.486 | 1.8 | log | |
| Odds ratio, group 1 over group 2 | 0.929 | 0.446 | 1.93 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Ropinirole PR-Ropinirole PR than on Ropinirole IR-Ropinirole PR | 142 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Ropinirole PR-Ropinirole PR | Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase. | 16 | 156 | EG000 |
| Group 2 | Ropinirole IR-Ropinirole PR | Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase. | 16 | 146 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54.
Source ClinicalTrials.gov
Trial
- Title
- Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease
- NCT number
- NCT00823836
- Phases
- PHASE3
- Conditions
- Parkinson Disease
- Interventions
- ropinirole PR/XR, ropinirole IR
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2011-10-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00823836?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT00823836-sae