Comparison · NCT03245151-de5d0912
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 Adverse Event (TEAE)
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 Adverse Event (TEAE). Trial comparisons, record NCT03245151-de5d0912. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03245151-de5d0912
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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 | 1 | 0.566 | 1 | wilson | |
| Risk in group 2 | 1 | 0.824 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.434 | 0.176 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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. | 5 | 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. | 18 | 18 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
- Description
A TEAE was defined as an adverse event that emerged during treatment, having been absent at pretreatment or reemerged during treatment, having been present at pretreatment but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the adverse event is continuous. 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.
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