TriangleNCT03257631 · OUTCOME
Kaplan-Meier Estimate of Progression-Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the first dose of pomalidomide to the date of the first documented tumor progression or death due to any cause, whichever occurs first (Up to 71 months)
What was measured
Progression-free survival was defined as the time from the date of first dose of pomalidomide until the date progressive disease (PD) was first observed or until the date of death due to any cause, whichever occurred first. Participants who did not have PD or had not died at the time of analysis were censored at the time of their last disease assessment or at the start of new anticancer therapy, whichever occurred first. Progressive Disease (PD): ≥ 25% increase in the size of the measurable lesions taking as a reference the smallest disease measurement recorded since the start of protocol therapy (nadir), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or if spine MRI and/or lumbar CSF cytology were previously negative and became positive.
Analysis population: The intent-to-treat population includes all enrolled participants, regardless of whether they received any treatment or not
Groups in this outcome
Diffuse Intrinsic Pontine Glioma
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Ependymoma
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
High-grade Glioma
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Medulloblastoma
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
| Group | Source count |
|---|---|
| Diffuse Intrinsic Pontine Glioma | 11 |
| Ependymoma | 9 |
| High-grade Glioma | 23 |
| Medulloblastoma | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Diffuse Intrinsic Pontine Glioma | 11.43 | Not reported | 4.43 | 12.57 | Not reported |
| Ependymoma | 8.43 | Not reported | 5.57 | 16.14 | Not reported |
| High-grade Glioma | 7.86 | Not reported | 5.43 | 8.29 | Not reported |
| Medulloblastoma | 8.29 | Not reported | 7.29 | 18.00 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.43
- upper Limit
- 12.57
- value
- 11.43
- group Id
- OG001
- lower Limit
- 5.57
- upper Limit
- 16.14
- value
- 8.43
- group Id
- OG002
- lower Limit
- 5.43
- upper Limit
- 8.29
- value
- 7.86
- group Id
- OG003
- lower Limit
- 7.29
- upper Limit
- 18.00
- value
- 8.29
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 23
- group Id
- OG003
- value
- 10
- units
- Participants
- description
- Progression-free survival was defined as the time from the date of first dose of pomalidomide until the date progressive disease (PD) was first observed or until the date of death due to any cause, whichever occurred first. Participants who did not have PD or had not died at the time of analysis were censored at the time of their last disease assessment or at the start of new anticancer therapy, whichever occurred first. Progressive Disease (PD): ≥ 25% increase in the size of the measurable lesions taking as a reference the smallest disease measurement recorded since the start of protocol therapy (nadir), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or if spine MRI and/or lumbar CSF cytology were previously negative and became positive.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
- id
- OG000
- title
- Diffuse Intrinsic Pontine Glioma
- description
- Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
- id
- OG001
- title
- Ependymoma
- description
- Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
- id
- OG002
- title
- High-grade Glioma
- description
- Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
- id
- OG003
- title
- Medulloblastoma
- param Type
- MEDIAN
- population Description
- The intent-to-treat population includes all enrolled participants, regardless of whether they received any treatment or not
- reporting Status
- POSTED
- time Frame
- From the first dose of pomalidomide to the date of the first documented tumor progression or death due to any cause, whichever occurs first (Up to 71 months)
- title
- Kaplan-Meier Estimate of Progression-Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- weeks
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice