TriangleNCT03295396 · OUTCOME
Duration of Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From objective response (complete response or partial response) per RANO to disease progression or death, up to 40.6 months.
What was measured
DOR is defined as the time from the first documented response to the earliest date of disease progression or death, whichever occurred first. Patients who had not progressed or died at the time of analysis were censored at their last adequate tumor assessment.
Analysis population: This outcome was analyzed in patients who achieved an objective response (complete response or partial response) per RANO criteria.
Groups in this outcome
Arm A
Patients received 625 mg dordaviprone (ONC201) once weekly. Arm A included patients with recurrent H3 K27M-mutant glioma including those with diffuse intrinsic pontine glioma (DIPG), primary spinal tumors, and some atypical histologies.
Arm B
Patients received 625 mg dordaviprone (ONC201) once weekly. Arm B included patients with recurrent H3 K27M-mutant glioma, but excluded patients with the following: * Primary malignant lesion located in the pons or spinal cord. * Atypical non-astrocytic histologies such as ependymoma, ganglioma and pleomorphic xanthoastrocytoma, or pilocytic astrocytoma and subependymal giant cell astrocytoma (SEGA). * Prior bevacizumab treatment of \>4 doses of \>7.5 mg/kg
| Group | Source count |
|---|---|
| Arm A | 5 |
| Arm B | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A | 5.6 | Not reported | 1.9 | NA | Not calculable. The statistical procedure did not have sufficient information (insufficient number of patients with events) in order to calculate the upper bound of the 95% confidence interval (CI). |
| Arm B | 15.0 | Not reported | 7.5 | NA | Not calculable. The statistical procedure did not have sufficient information (insufficient number of patients with events) in order to calculate the upper bound of the 95% confidence interval (CI). |
Complete source fields
- classes
- categories
- measurements
- comment
- Not calculable. The statistical procedure did not have sufficient information (insufficient number of patients with events) in order to calculate the upper bound of the 95% confidence interval (CI).
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- NA
- value
- 5.6
- comment
- Not calculable. The statistical procedure did not have sufficient information (insufficient number of patients with events) in order to calculate the upper bound of the 95% confidence interval (CI).
- group Id
- OG001
- lower Limit
- 7.5
- upper Limit
- NA
- value
- 15.0
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- DOR is defined as the time from the first documented response to the earliest date of disease progression or death, whichever occurred first. Patients who had not progressed or died at the time of analysis were censored at their last adequate tumor assessment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients received 625 mg dordaviprone (ONC201) once weekly. Arm A included patients with recurrent H3 K27M-mutant glioma including those with diffuse intrinsic pontine glioma (DIPG), primary spinal tumors, and some atypical histologies.
- id
- OG000
- title
- Arm A
- description
- Patients received 625 mg dordaviprone (ONC201) once weekly. Arm B included patients with recurrent H3 K27M-mutant glioma, but excluded patients with the following: * Primary malignant lesion located in the pons or spinal cord. * Atypical non-astrocytic histologies such as ependymoma, ganglioma and pleomorphic xanthoastrocytoma, or pilocytic astrocytoma and subependymal giant cell astrocytoma (SEGA). * Prior bevacizumab treatment of \>4 doses of \>7.5 mg/kg
- id
- OG001
- title
- Arm B
- param Type
- MEDIAN
- population Description
- This outcome was analyzed in patients who achieved an objective response (complete response or partial response) per RANO criteria.
- reporting Status
- POSTED
- time Frame
- From objective response (complete response or partial response) per RANO to disease progression or death, up to 40.6 months.
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice