Comparison · NCT03245151-43ac0824
Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 vs Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2: Phase 1: Number of Participants With Any Treatment-emergent Serious Adverse Event (TESAE)
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. Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 vs Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2: Phase 1: Number of Participants With Any Treatment-emergent Serious Adverse Event (TESAE). Trial comparisons, record NCT03245151-43ac0824. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03245151-43ac0824
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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 | 0.118 | 0.769 | wilson | |
| Risk in group 2 | 0.667 | 0.437 | 0.837 | wilson | |
| Risk difference, group 1 minus group 2 | -0.267 | -0.597 | 0.168 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.6 | 0.195 | 1.84 | log | |
| Odds ratio, group 1 over group 2 | 0.333 | 0.0433 | 2.56 | log | |
| Number needed to treat, for one fewer participant with the outcome on Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 than on Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 3.75 | 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 | Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | Participants with recurrent or refractory solid tumors received lenvatinib 8 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first. | 2 | 5 | OG000 |
| Group 2 | Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first. | 12 | 18 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Phase 1: Number of Participants With Any Treatment-emergent Serious Adverse Event (TESAE)
- Description
A TESAE was any untoward medical occurrence that at any dose: resulted in death; life threatening condition; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was medically important due to other reasons than the above mentioned criteria. An adverse event was defined as any untoward medical occurrence in a participant administered an investigational product.
- Time frame
- From date of first dose up to 28 days after the last dose of study treatment (Up to 17.5 months)
- Population
- SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus).
Source ClinicalTrials.gov
Trial
- Title
- Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors
- NCT number
- NCT03245151
- Phases
- PHASE1, PHASE2
- Conditions
- Recurrent and Refractory Solid Tumors
- Interventions
- Lenvatinib, Everolimus
- Lead sponsor
- Eisai Inc.
- Results first posted
- 2023-08-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03245151?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.
For software
Read this comparison from software.
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GET https://conductscience.org/api/comparisons/v1/NCT03245151-43ac0824