Comparison · NCT05440786-sae
Abemaciclib + Irinotecan +Temozolomide vs Irinotecan +Temozolomide: 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. Abemaciclib + Irinotecan +Temozolomide vs Irinotecan +Temozolomide: serious adverse events. Trial comparisons, record NCT05440786-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05440786-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 | 0.4 | 0.246 | 0.577 | wilson | |
| Risk in group 2 | 0.333 | 0.152 | 0.583 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0667 | -0.227 | 0.32 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.2 | 0.518 | 2.78 | log | |
| Odds ratio, group 1 over group 2 | 1.33 | 0.364 | 4.88 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Abemaciclib + Irinotecan +Temozolomide than on Irinotecan +Temozolomide | 15 | 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 | Abemaciclib + Irinotecan +Temozolomide | Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met.~* Abemaciclib: 55 mg/m², administered orally BID for \<18 years or 100 mg administered orally BID for ≥18 years.~* Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.~* Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle. | 12 | 30 | EG000 |
| Group 2 | Irinotecan +Temozolomide | Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met.~* Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.~* Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle. | 5 | 15 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to end of follow-up (up to 26.37 months)
Source ClinicalTrials.gov
Trial
- Title
- CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma
- NCT number
- NCT05440786
- Phases
- PHASE2
- Conditions
- Sarcoma, Ewing, Neoplasm Metastasis
- Interventions
- Abemaciclib, Irinotecan, Temozolomide
- Lead sponsor
- Eli Lilly and Company
- Results first posted
- 2026-03-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05440786?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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