Comparison · NCT01281475-sae
Levodopa 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
Cite this record
ConductScience Library. Levodopa vs Placebo: serious adverse events. Trial comparisons, record NCT01281475-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01281475-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 | 0.0909 | 0.0314 | 0.236 | wilson | |
| Risk in group 2 | 0.0294 | 0.00521 | 0.149 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0615 | -0.0722 | 0.208 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.09 | 0.338 | 28.2 | log | |
| Odds ratio, group 1 over group 2 | 3.3 | 0.325 | 33.5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Levodopa than on Placebo | 16.3 | 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 | Levodopa | Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.~Levodopa/carbidopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day. | 3 | 33 | EG000 |
| Group 2 | Placebo | The placebo (in this study, microcellulose) is not expected to have any effect. | 1 | 34 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Trial of Levodopa in Angelman Syndrome
- NCT number
- NCT01281475
- Phases
- PHASE2, PHASE3
- Conditions
- Angelman Syndrome
- Interventions
- Levodopa, Placebo Oral Capsule
- Lead sponsor
- Wen-Hann Tan
- Results first posted
- 2017-01-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01281475?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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