Comparison · NCT04120402-sae
EP-104IAR 25 mg vs Placebo (Vehicle): 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. EP-104IAR 25 mg vs Placebo (Vehicle): serious adverse events. Trial comparisons, record NCT04120402-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04120402-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 | 0.0245 | 0.00958 | 0.0614 | wilson | |
| Risk in group 2 | 0.00645 | 0.00114 | 0.0356 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0181 | -0.0147 | 0.0553 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.8 | 0.43 | 33.7 | log | |
| Odds ratio, group 1 over group 2 | 3.87 | 0.428 | 35.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on EP-104IAR 25 mg than on Placebo (Vehicle) | 55.3 | 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 | EP-104IAR 25 mg | A single use intra-articular injection containing 25 mg of EP-104IAR~EP-104IAR 25 mg: Single 5 mL intra-articular injection | 4 | 163 | EG000 |
| Group 2 | Placebo (Vehicle) | A single use intra-articular injection containing no active ingredients~Vehicle: Single 5 mL intra-articular injection | 1 | 155 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Treatment-emergent adverse events (TEAEs) were summarized and analyzed for safety evaluations i.e, events which occurred from the time of the EP-104IAR or vehicle injection procedure until the Week 24/End-of-Study/Early Exit Visit.
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Efficacy and Safety of EP-104IAR in Patients With Osteoarthritis of the Knee
- NCT number
- NCT04120402
- Phases
- PHASE2
- Conditions
- Osteoarthritis, Knee
- Interventions
- EP-104IAR 25 mg, Vehicle
- Lead sponsor
- Eupraxia Pharmaceuticals Inc.
- Results first posted
- 2024-06-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04120402?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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