Comparison · NCT05269355-sae
Unesbulin and Dacarbazine vs Placebo and Dacarbazine: 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. Unesbulin and Dacarbazine vs Placebo and Dacarbazine: serious adverse events. Trial comparisons, record NCT05269355-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05269355-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 | 0.34 | 0.283 | 0.403 | wilson | |
| Risk in group 2 | 0.358 | 0.278 | 0.447 | wilson | |
| Risk difference, group 1 minus group 2 | -0.018 | -0.124 | 0.0835 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.95 | 0.705 | 1.28 | log | |
| Odds ratio, group 1 over group 2 | 0.924 | 0.584 | 1.46 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Unesbulin and Dacarbazine than on Placebo and Dacarbazine | 55.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Unesbulin and Dacarbazine | Participants received unesbulin 300 mg tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason. | 81 | 238 | EG000 |
| Group 2 | Placebo and Dacarbazine | Participants received placebo matching to unesbulin tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason. | 43 | 120 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study drug up to approximately 2 years
Source ClinicalTrials.gov
Trial
- Title
- A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS)
- NCT number
- NCT05269355
- Phases
- PHASE2, PHASE3
- Conditions
- Leiomyosarcoma
- Interventions
- Unesbulin, Dacarbazine, Placebo
- Lead sponsor
- PTC Therapeutics
- Results first posted
- 2025-06-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05269355?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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