TriangleNCT02162732 · OUTCOME
Progression Free Survival (PFS) Interval Will be Measured by Days and Compared to the PFS of Previous Chemotherapy Regimens Since Relapse for Each Patient.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Days
- Interval / dispersion
- Full Range
- Time frame
- From date of start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years
What was measured
Time to progression (PFS), defined as the period from the start of the treatment until the criteria for progression are met taking as reference the screening measurements. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the disease measurements for measurable lesions, taking as reference the smallest disease measurement recorded since the start of treatment (nadir), and minimum 5 mm increase over the nadir or the appearance of one or more new lesions or appearance of positive bone marrow.
Analysis population: Time on study was measured in days from the date of initial biopsy to date of last administration of study therapy. For subjects with \>1 biopsies and \>1 MGT regimens, the off-therapy date from their last treatment was used.
Groups in this outcome
Neuroblastoma
Subjects on study with a diagnosis of Neuroblastoma
CNS Tumors
Subjects on study with a diagnosis of a CNS Tumor which included, but was not limited to, Ependymoma, Glioblastoma, Diffuse Midline Glioma, and Other CNS Tumors.
Rare Tumors
Subjects on study with a diagnosis of a rare solid tumor which included, but was not limited to, Rhabdomyosarcoma, Ewing Sarcoma, Osteosarcoma, and Other Rare Tumors.
| Group | Source count |
|---|---|
| Neuroblastoma | 27 |
| CNS Tumors | 37 |
| Rare Tumors | 60 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Neuroblastoma | 153 | Not reported | 45 | 556 | Not reported |
| CNS Tumors | 283 | Not reported | 50 | 1415 | Not reported |
| Rare Tumors | 163 | Not reported | 28 | 1317 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 45
- upper Limit
- 556
- value
- 153
- group Id
- OG001
- lower Limit
- 50
- upper Limit
- 1415
- value
- 283
- group Id
- OG002
- lower Limit
- 28
- upper Limit
- 1317
- value
- 163
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 37
- group Id
- OG002
- value
- 60
- units
- Participants
- description
- Time to progression (PFS), defined as the period from the start of the treatment until the criteria for progression are met taking as reference the screening measurements. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the disease measurements for measurable lesions, taking as reference the smallest disease measurement recorded since the start of treatment (nadir), and minimum 5 mm increase over the nadir or the appearance of one or more new lesions or appearance of positive bone marrow.
- dispersion Type
- Full Range
- groups
- description
- Subjects on study with a diagnosis of Neuroblastoma
- id
- OG000
- title
- Neuroblastoma
- description
- Subjects on study with a diagnosis of a CNS Tumor which included, but was not limited to, Ependymoma, Glioblastoma, Diffuse Midline Glioma, and Other CNS Tumors.
- id
- OG001
- title
- CNS Tumors
- description
- Subjects on study with a diagnosis of a rare solid tumor which included, but was not limited to, Rhabdomyosarcoma, Ewing Sarcoma, Osteosarcoma, and Other Rare Tumors.
- id
- OG002
- title
- Rare Tumors
- param Type
- MEAN
- population Description
- Time on study was measured in days from the date of initial biopsy to date of last administration of study therapy. For subjects with \>1 biopsies and \>1 MGT regimens, the off-therapy date from their last treatment was used.
- reporting Status
- POSTED
- time Frame
- From date of start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years
- title
- Progression Free Survival (PFS) Interval Will be Measured by Days and Compared to the PFS of Previous Chemotherapy Regimens Since Relapse for Each Patient.
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice