Comparison · NCT01575054-sae
Botulinum Toxin Type A vs Normal Saline (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. Botulinum Toxin Type A vs Normal Saline (Placebo): serious adverse events. Trial comparisons, record NCT01575054-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01575054-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 | 0.0433 | 0.0237 | 0.0778 | wilson | |
| Risk in group 2 | 0.0386 | 0.0205 | 0.0718 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00466 | -0.0338 | 0.0437 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.12 | 0.464 | 2.71 | log | |
| Odds ratio, group 1 over group 2 | 1.13 | 0.449 | 2.82 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Botulinum Toxin Type A than on Normal Saline (Placebo) | 214 | 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 | Botulinum Toxin Type A | Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. | 10 | 231 | EG000 |
| Group 2 | Normal Saline (Placebo) | Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. | 9 | 233 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity
- NCT number
- NCT01575054
- Phases
- PHASE3
- Conditions
- Muscle Spasticity
- Interventions
- botulinum toxin Type A, Normal Saline
- Lead sponsor
- Allergan
- Results first posted
- 2016-02-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01575054?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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