TriangleNCT04154189 · OUTCOME
Progression-free Survival (PFS) by Independent Imaging Review (IIR) Assessment
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 the first documentation of PD or date of death, whichever occurred first (up to 20.5 months)
What was measured
PFS as assessed by IIR was defined as the time from the date of randomization to the date of the first documentation of PD or date of death (whichever occurred first), as determined using RECIST v1.1. PD was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was analyzed using Kaplan-Meier 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 | 6.5 | Not reported | 5.7 | 8.2 | Not reported |
| Treatment Arm B: Ifosfamide + Etoposide | 5.5 | Not reported | 2.9 | 6.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.27
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.08
- estimate Comment
- Hazard ratio was based on Cox Proportional Hazard Model including treatment group as a factor and stratified by Age (less than \[\<\]18 years, more than or equal to \[\>=\]18 years) in interactive response technology (IRT). Efron method was used for ties.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0396
- p Value Comment
- One-sided P value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.54
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.27
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.08
- estimate Comment
- Hazard ratio was based on Cox Proportional Hazard Model including treatment group as a factor and stratified by Age (less than \[\<\]18 years, more than or equal to \[\>=\]18 years) in interactive response technology (IRT). Efron method was used for ties.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0396
- p Value Comment
- One-sided P value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.54
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.7
- upper Limit
- 8.2
- value
- 6.5
- group Id
- OG001
- lower Limit
- 2.9
- upper Limit
- 6.5
- value
- 5.5
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 41
- units
- Participants
- description
- PFS as assessed by IIR was defined as the time from the date of randomization to the date of the first documentation of PD or date of death (whichever occurred first), as determined using RECIST v1.1. PD was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was analyzed using Kaplan-Meier 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 the first documentation of PD or date of death, whichever occurred first (up to 20.5 months)
- title
- Progression-free Survival (PFS) by Independent Imaging Review (IIR) Assessment
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice