Comparison · NCT04385303-sae
Lorecivivint vs 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. Lorecivivint vs Vehicle: serious adverse events. Trial comparisons, record NCT04385303-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04385303-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 | 0.0166 | 0.00647 | 0.0419 | wilson | |
| Risk in group 2 | 0.00398 | 0.000704 | 0.0222 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0126 | -0.00824 | 0.0381 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 4.17 | 0.469 | 37 | log | |
| Odds ratio, group 1 over group 2 | 4.22 | 0.468 | 38 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Lorecivivint than on Vehicle | 79.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: vehicle.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Lorecivivint | Healthcare professional-administered intra-articular injection; performed on Day 1.~Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle | 4 | 241 | EG001 |
| Group 2 | Vehicle | Healthcare professional-administered intra-articular injection; performed on Day 1.~Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle | 1 | 251 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
Source ClinicalTrials.gov
Trial
- Title
- Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1)
- NCT number
- NCT04385303
- Phases
- PHASE3
- Conditions
- Knee Osteoarthritis
- Interventions
- Lorecivivint, Placebo
- Lead sponsor
- Biosplice Therapeutics, Inc.
- Results first posted
- 2026-02-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04385303?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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