TriangleNCT03257631 · OUTCOME
Percentage of Participants With an Objective Response and Long-term Stable Disease
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 6 months (first 6 cycles) or 3 months (first 3 cycles) for participants in the DIPG group
What was measured
The percentage of participants who achieved either an objective response, defined as a complete response (CR) or partial response (PR) in the first 6 cycles of treatment (or within 3 cycles for DIPG), or long-term stable disease (SD) defined as SD maintained for ≥ 6 cycles (≥ 3 cycles for DIPG), measured from first dose date. CR: Disappearance of all lesions and no new lesions. PR: A reduction of ≥ 50% in the size of measurable lesions, and/or persistence of non-target lesions with no progression or decrease in size. SD: A decrease of \< 50% or an increase of \< 25% in the size of measurable lesions and no evidence of new lesions, response does not meet the criteria for CR, PR, or progressive disease, and/or the persistence of non-target lesions with no progression or decrease in size. Progressive Disease (PD): ≥ 25% increase in the size of the measurable lesions, or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Analysis population: The response population consisted of all enrolled participants receiving at least one cycle of pomalidomide if therapy was not discontinued earlier due to progressive disease (PD)
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 | 9 |
| Ependymoma | 9 |
| High-grade Glioma | 19 |
| Medulloblastoma | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Diffuse Intrinsic Pontine Glioma | 0 | Not reported | 0.0 | 33.6 | Not reported |
| Ependymoma | 11.1 | Not reported | 0.3 | 48.2 | Not reported |
| High-grade Glioma | 10.5 | Not reported | 1.3 | 33.1 | Not reported |
| Medulloblastoma | 0 | Not reported | 0.0 | 33.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 33.6
- value
- 0
- group Id
- OG001
- lower Limit
- 0.3
- upper Limit
- 48.2
- value
- 11.1
- group Id
- OG002
- lower Limit
- 1.3
- upper Limit
- 33.1
- value
- 10.5
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 33.6
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 9
- units
- Participants
- description
- The percentage of participants who achieved either an objective response, defined as a complete response (CR) or partial response (PR) in the first 6 cycles of treatment (or within 3 cycles for DIPG), or long-term stable disease (SD) defined as SD maintained for ≥ 6 cycles (≥ 3 cycles for DIPG), measured from first dose date. CR: Disappearance of all lesions and no new lesions. PR: A reduction of ≥ 50% in the size of measurable lesions, and/or persistence of non-target lesions with no progression or decrease in size. SD: A decrease of \< 50% or an increase of \< 25% in the size of measurable lesions and no evidence of new lesions, response does not meet the criteria for CR, PR, or progressive disease, and/or the persistence of non-target lesions with no progression or decrease in size. Progressive Disease (PD): ≥ 25% increase in the size of the measurable lesions, or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
- 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
- NUMBER
- population Description
- The response population consisted of all enrolled participants receiving at least one cycle of pomalidomide if therapy was not discontinued earlier due to progressive disease (PD)
- reporting Status
- POSTED
- time Frame
- 6 months (first 6 cycles) or 3 months (first 3 cycles) for participants in the DIPG group
- title
- Percentage of Participants With an Objective Response and Long-term Stable Disease
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice