TriangleNCT04154189 · OUTCOME
Change From Baseline in PedsQL Scale: Cancer Module Scale Score at Month 4
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and Month 4
What was measured
HRQoL: PedsQL 3.0 Cancer Module Scale measured pediatric cancer-specific HRQoL. It included assessment of 8 dimensions: pain and hurt (2 items), nausea (5 items), procedural anxiety (3 items), treatment anxiety (3 items), worry (3 items), cognitive problems (3 items - toddlers \[aged 2-4\], 4 items - young children \[aged 5-7\]; 5 items for children aged \>=8 years, adults), perceived physical appearance (3 items), communication (3 items). Each item was reported using a 5-point Likert scale, items were then reverse-scored and linearly transformed to a 0 to 100 scale. Cancer Module total score: sum of all items divided by the number of items answered on all the scales. Total score ranges from 0 to 100, where higher scores=better HRQoL, lower scores=worse HRQoL.
Analysis population: HRQoL Analysis Set included all participants who had received at least 1 dose of study drug and had completed at least 1 postbaseline PRO assessment. Here "overall number of participants analyzed, N" signifies participants who were evaluable for this outcome measure.
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 | 16 |
| Treatment Arm B: Ifosfamide + Etoposide | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide | 2.66 | 9.989 | Not reported | Not reported | Not reported |
| Treatment Arm B: Ifosfamide + Etoposide | 2.08 | 6.736 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 9.989
- value
- 2.66
- group Id
- OG001
- spread
- 6.736
- value
- 2.08
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- HRQoL: PedsQL 3.0 Cancer Module Scale measured pediatric cancer-specific HRQoL. It included assessment of 8 dimensions: pain and hurt (2 items), nausea (5 items), procedural anxiety (3 items), treatment anxiety (3 items), worry (3 items), cognitive problems (3 items - toddlers \[aged 2-4\], 4 items - young children \[aged 5-7\]; 5 items for children aged \>=8 years, adults), perceived physical appearance (3 items), communication (3 items). Each item was reported using a 5-point Likert scale, items were then reverse-scored and linearly transformed to a 0 to 100 scale. Cancer Module total score: sum of all items divided by the number of items answered on all the scales. Total score ranges from 0 to 100, where higher scores=better HRQoL, lower scores=worse HRQoL.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- HRQoL Analysis Set included all participants who had received at least 1 dose of study drug and had completed at least 1 postbaseline PRO assessment. Here "overall number of participants analyzed, N" signifies participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline and Month 4
- title
- Change From Baseline in PedsQL Scale: Cancer Module Scale Score at Month 4
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice