Comparison · NCT00996944-sae
Ropinirole IR-Ropinirole IR vs Placebo-Ropinirole IR: 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 IR-Ropinirole IR vs Placebo-Ropinirole IR: serious adverse events. Trial comparisons, record NCT00996944-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00996944-sae
On this page
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 | 0.0455 | 0.00807 | 0.218 | wilson | |
| Risk in group 2 | 0.0833 | 0.0149 | 0.354 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0379 | -0.311 | 0.148 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.545 | 0.0374 | 7.96 | log | |
| Odds ratio, group 1 over group 2 | 0.524 | 0.0298 | 9.2 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Ropinirole IR-Ropinirole IR than on Placebo-Ropinirole IR | 26.4 | 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 IR-Ropinirole IR | Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting much improved or very much improved in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period. | 1 | 22 | EG000 |
| Group 2 | Placebo-Ropinirole IR | Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group. | 1 | 12 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
Source ClinicalTrials.gov
Trial
- Title
Clinical Evaluation of Ropinirole IR (Immediate Release) Tablets in Patients Who Are Diagnosed With Symptomatic Restless Legs Syndrome (RLS) Associated With Chronic Kidney Disease (CKD) Managed With Haemodialysis (Including Haemofiltration and Haemodiafiltration)
- NCT number
- NCT00996944
- Phases
- PHASE2
- Conditions
- Restless Legs Syndrome
- Interventions
- Ropinirole immediate release (IR), Placebo
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2011-06-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00996944?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00996944-sae