Comparison · NCT00533273-sae
AA4500 0.58 mg 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. AA4500 0.58 mg vs Placebo: serious adverse events. Trial comparisons, record NCT00533273-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00533273-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 | 0.111 | 0.0549 | 0.212 | wilson | |
| Risk in group 2 | 0.0476 | 0.00846 | 0.227 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0635 | -0.124 | 0.172 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.33 | 0.305 | 17.9 | log | |
| Odds ratio, group 1 over group 2 | 2.5 | 0.289 | 21.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on AA4500 0.58 mg than on Placebo | 15.8 | 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 | AA4500 0.58 mg | collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints | 7 | 63 | EG000 |
| Group 2 | Placebo | Placebo injection is comprised of sucrose and Tris | 1 | 21 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study.
Source ClinicalTrials.gov
Trial
- Title
- Non-US Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
- NCT number
- NCT00533273
- Phases
- PHASE3
- Conditions
- Advanced Dupuytren's Disease
- Interventions
- collagenase clostridium histolyticum
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Results first posted
- 2010-10-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00533273?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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