TriangleNCT04154189 · OUTCOME
Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the date of randomization to the date of death from any cause (up to 37.1 months)
What was measured
OS was defined as the time from the date of randomization to the date of death from any cause. The median OS was from Kaplan-Meier product-limit estimates and 2-sided 95% CIs from a generalized Brookmeyer and Crowley method.
Analysis population: FAS included all randomized participants regardless of the treatment actually received.
Groups in this outcome
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
Treatment Arm B: Ifosfamide + Etoposide
Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
| Group | Source count |
|---|---|
| Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide | 40 |
| Treatment Arm B: Ifosfamide + Etoposide | 41 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide | 12.4 | Not reported | 10.4 | 19.8 | Not reported |
| Treatment Arm B: Ifosfamide + Etoposide | 17.2 | Not reported | 11.1 | 22.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.62
- estimate Comment
- Hazard ratio was based on a Cox Proportional Hazard Model including treatment group as a factor and stratified by Age (\<18 years, \>=18 years) in IRT. Efron method was used for ties.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.3924
- p Value Comment
- Nominal p-value from stratified log-rank test adjusted for the randomization stratification factor, that is, age.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.93
- statistical Method
- Stratified Log-rank One-sided Test
Complete source fields
- analyses
- ci Lower Limit
- 0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.62
- estimate Comment
- Hazard ratio was based on a Cox Proportional Hazard Model including treatment group as a factor and stratified by Age (\<18 years, \>=18 years) in IRT. Efron method was used for ties.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.3924
- p Value Comment
- Nominal p-value from stratified log-rank test adjusted for the randomization stratification factor, that is, age.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.93
- statistical Method
- Stratified Log-rank One-sided Test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.4
- upper Limit
- 19.8
- value
- 12.4
- group Id
- OG001
- lower Limit
- 11.1
- upper Limit
- 22.3
- value
- 17.2
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 41
- units
- Participants
- description
- OS was defined as the time from the date of randomization to the date of death from any cause. The median OS was from Kaplan-Meier product-limit estimates and 2-sided 95% CIs from a generalized Brookmeyer and Crowley method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
- id
- OG000
- title
- Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
- description
- Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
- id
- OG001
- title
- Treatment Arm B: Ifosfamide + Etoposide
- param Type
- MEDIAN
- population Description
- FAS included all randomized participants regardless of the treatment actually received.
- reporting Status
- POSTED
- time Frame
- From the date of randomization to the date of death from any cause (up to 37.1 months)
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice