Comparison · NCT03727022-sae
0.07 mg SM04690 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. 0.07 mg SM04690 vs Vehicle: serious adverse events. Trial comparisons, record NCT03727022-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03727022-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 | 0.0392 | 0.0108 | 0.132 | wilson | |
| Risk in group 2 | 0.04 | 0.011 | 0.135 | wilson | |
| Risk difference, group 1 minus group 2 | -0.000784 | -0.0996 | 0.0966 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.98 | 0.144 | 6.69 | log | |
| Odds ratio, group 1 over group 2 | 0.98 | 0.133 | 7.24 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on 0.07 mg SM04690 than on Vehicle | 1,270 | 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 | 0.07 mg SM04690 | Intra-articular injections of 0.07 mg SM04690 in 2 mL vehicle~SM04690: Healthcare professional-administered intra-articular injections; first performed on Day 1 and second at Week 24. (In the extension phase, healthcare professional-administered intra-articular injections; first performed at Week 52 and second at Week 76.) | 2 | 51 | EG000 |
| Group 2 | Vehicle | Intra-articular injections of 0 mg SM04690 in 2 mL vehicle~Placebo: Healthcare professional-administered intra-articular injections; first performed on Day 1 and second at Week 24. (In the extension phase, healthcare professional-administered intra-articular injections; first performed at Week 52 and second at Week 76.) | 2 | 50 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline to End of Study Visit at Week 104 (2 years)
Source ClinicalTrials.gov
Trial
- Title
- Safety and Bone Health Study of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
- NCT number
- NCT03727022
- Phases
- PHASE2
- Conditions
- Knee Osteoarthritis
- Interventions
- Placebo, SM04690
- Lead sponsor
- Biosplice Therapeutics, Inc.
- Results first posted
- 2026-01-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03727022?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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