Comparison · NCT02006719-sae
AA4500 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 vs Placebo: serious adverse events. Trial comparisons, record NCT02006719-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02006719-sae
On this page
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 | 0.0169 | 0.00658 | 0.0426 | wilson | |
| Risk in group 2 | 0.0119 | 0.0021 | 0.0644 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00497 | -0.0485 | 0.0325 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.42 | 0.161 | 12.5 | log | |
| Odds ratio, group 1 over group 2 | 1.42 | 0.157 | 12.9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on AA4500 than on Placebo | 201 | 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 | Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise | 4 | 237 | EG000 |
| Group 2 | Placebo | Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise | 1 | 84 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 130 days (up to 28 day screening period and 95±7 day study period)
Source ClinicalTrials.gov
Trial
- Title
- Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder
- NCT number
- NCT02006719
- Phases
- PHASE2
- Conditions
- Adhesive Capsulitis, Frozen Shoulder
- Interventions
- Collagenase Clostridium Histolyticum, Placebo
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Results first posted
- 2017-05-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02006719?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02006719-sae