Comparison · NCT00748098-sae
GEn 1200 mg vs Placebo: 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. GEn 1200 mg vs Placebo: serious adverse events. Trial comparisons, record NCT00748098-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00748098-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 | 0.0157 | 0.00433 | 0.0556 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0283 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0157 | -0.0147 | 0.0556 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on GEn 1200 mg than on Placebo | 63.5 | 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 | GEn 1200 mg | Participants who took at least one dose of GEn 1200 mg in either the first intervention period or the second intervention period. Of the 136 participants in the Safety Population, 127 took at least one dose of GEn 1200 mg. | 2 | 127 | EG001 |
| Group 2 | Placebo | Participants who took at least one dose of placebo in either the first intervention period or the second intervention period. Of the 136 participants in the Safety Population, 132 took at least one dose of placebo. | 0 | 132 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 12).
Source ClinicalTrials.gov
Trial
- Title
- Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance
- NCT number
- NCT00748098
- Phases
- PHASE3
- Conditions
- Restless Legs Syndrome, Restless Legs Syndrome (RLS)
- Interventions
- GSK1838262 Extended Release Tablets, Placebo
- Lead sponsor
- XenoPort, Inc.
- Results first posted
- 2011-05-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00748098?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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