Comparison · NCT00465738-606fd0b3
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL vs incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL: Responder in FAT at Week 12 - Full Analysis Set
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. incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL vs incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL: Responder in FAT at Week 12 - Full Analysis Set. Trial comparisons, record NCT00465738-606fd0b3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00465738-606fd0b3
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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 | 0.213 | 0.142 | 0.306 | wilson | |
| Risk in group 2 | 0.232 | 0.158 | 0.326 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0188 | -0.137 | 0.0998 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.919 | 0.539 | 1.57 | log | |
| Odds ratio, group 1 over group 2 | 0.897 | 0.451 | 1.78 | log | |
| Number needed to treat, for one fewer participant with the outcome on incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL than on incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 53.2 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL | 20 | 94 | OG000 | |
| Group 2 | incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 22 | 95 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Responder in FAT at Week 12 - Full Analysis Set
- Description
Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.
- Time frame
- Week 12
- Population
- Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Source ClinicalTrials.gov
Trial
- Title
- IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity
- NCT number
- NCT00465738
- Phases
- PHASE3
- Conditions
- Upper Limb Spasticity
- Interventions
- incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Results first posted
- 2010-12-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00465738?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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