Comparison · NCT01153815-sae
BTX 200 U 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. BTX 200 U vs Placebo: serious adverse events. Trial comparisons, record NCT01153815-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01153815-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 | 0.023 | 0.00633 | 0.08 | wilson | |
| Risk in group 2 | 0.012 | 0.00213 | 0.0651 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0109 | -0.0447 | 0.0688 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.91 | 0.176 | 20.6 | log | |
| Odds ratio, group 1 over group 2 | 1.93 | 0.172 | 21.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on BTX 200 U than on Placebo | 91.4 | 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 | BTX 200 U | Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | 2 | 87 | EG001 |
| Group 2 | Placebo | Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | 1 | 83 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Upper Limb Spasticity
- NCT number
- NCT01153815
- Phases
- PHASE3
- Conditions
- Cerebrovascular Accident
- Interventions
- GSK1358820(Botulinum toxin type A), placebo
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2012-05-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01153815?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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