Comparison · NCT00661089-sae
onabotulinumtoxinA Injection vs Saline Injection: 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. onabotulinumtoxinA Injection vs Saline Injection: serious adverse events. Trial comparisons, record NCT00661089-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00661089-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 | 0.1 | 0.0179 | 0.404 | wilson | |
| Risk in group 2 | 0.364 | 0.152 | 0.646 | wilson | |
| Risk difference, group 1 minus group 2 | -0.264 | -0.558 | 0.107 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.275 | 0.0366 | 2.07 | log | |
| Odds ratio, group 1 over group 2 | 0.194 | 0.0176 | 2.15 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on onabotulinumtoxinA Injection than on Saline Injection | 3.79 | 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 | onabotulinumtoxinA Injection | Botulinum Toxin injected at second visit | 1 | 10 | EG000 |
| Group 2 | Saline Injection | Receives placebo injections following randomization (Saline).Delayed treatment group.~Blind broken and receives botulinum toxin at week 12 | 4 | 11 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From enrollment through 12 weeks post injection
Source ClinicalTrials.gov
Trial
- Title
- Randomized DB Controlled Trial of Botulinum Toxin A in Hemiplegic Shoulder Pain and Spasticity
- NCT number
- NCT00661089
- Phases
- NA
- Conditions
- Post-stroke Shoulder Pain and Spasticity
- Interventions
- Botulinum Toxin Type A - OnabotulinumtoxinA, Placebo (Saline)
- Lead sponsor
- Shirley Ryan AbilityLab
- Results first posted
- 2012-02-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00661089?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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