TriangleNCT01462695 · OUTCOME
Sustained Objective Response Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 5 years
What was measured
Sustained objective response was defined as a PR (Partial Response: ≥ 50% decrease in the sum of the products of the 2 perpendicular diameters of all target lesions (up to 5), taking as reference the initial baseline measurements) or CR (Complete Response: disappearance of all target lesions) lasting at least 8 weeks.
Analysis population: One patient in Stratum A was excluded because the patient did not receive study drug and therefore was not evaluable for response.
Groups in this outcome
Stratum A: Recurrent High Grade Glioma
Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO diagnostic laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Stratum B: Recurrent Ependymoma
Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO diagnostic laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
| Group | Source count |
|---|---|
| Stratum A: Recurrent High Grade Glioma | 16 |
| Stratum B: Recurrent Ependymoma | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum A: Recurrent High Grade Glioma | 0 | Not reported | 0 | 19.8 | Not reported |
| Stratum B: Recurrent Ependymoma | 0 | Not reported | 0 | 22.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 19.8
- value
- 0
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 22.5
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- Sustained objective response was defined as a PR (Partial Response: ≥ 50% decrease in the sum of the products of the 2 perpendicular diameters of all target lesions (up to 5), taking as reference the initial baseline measurements) or CR (Complete Response: disappearance of all target lesions) lasting at least 8 weeks.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO diagnostic laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
- id
- OG000
- title
- Stratum A: Recurrent High Grade Glioma
- description
- Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO diagnostic laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
- id
- OG001
- title
- Stratum B: Recurrent Ependymoma
- param Type
- NUMBER
- population Description
- One patient in Stratum A was excluded because the patient did not receive study drug and therefore was not evaluable for response.
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Sustained Objective Response Rate
- type
- PRIMARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice