TriangleNCT03389802 · OUTCOME
Progression-free Survival for Stratum 2 (DIPG) Patients
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percent probability
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 1 year
What was measured
Progression-free survival (PFS) was defined as the time interval from treatment initiation to date of first event (relapsed or progressive disease based on imaging or clinical progression or death from any cause) or to the date of last follow-up for patients without events. PFS was estimated using the method of Kaplan and Meier. The 1-year estimate of PFS is reported with a 95% confidence interval. PFS estimates were reported separately by dose level. Stratum 2 patients were those with newly diagnosed diffuse intrinsic pontine glioma (DIPG).
Analysis population: Newly diagnosed DIPG patients who were enrolled on Stratum 2 and received at least one dose of APX005M are included in this analysis.
Groups in this outcome
Stratum 2, Dose Level 2
Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Stratum 2, Dose Level 3
Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
| Group | Source count |
|---|---|
| Stratum 2, Dose Level 2 | 6 |
| Stratum 2, Dose Level 3 | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 2, Dose Level 2 | 16.7 | Not reported | 0.0 | 37.9 | Not reported |
| Stratum 2, Dose Level 3 | 26.7 | Not reported | 0.0 | 58.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 37.9
- value
- 16.7
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 58.3
- value
- 26.7
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- Progression-free survival (PFS) was defined as the time interval from treatment initiation to date of first event (relapsed or progressive disease based on imaging or clinical progression or death from any cause) or to the date of last follow-up for patients without events. PFS was estimated using the method of Kaplan and Meier. The 1-year estimate of PFS is reported with a 95% confidence interval. PFS estimates were reported separately by dose level. Stratum 2 patients were those with newly diagnosed diffuse intrinsic pontine glioma (DIPG).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
- id
- OG000
- title
- Stratum 2, Dose Level 2
- description
- Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
- id
- OG001
- title
- Stratum 2, Dose Level 3
- param Type
- NUMBER
- population Description
- Newly diagnosed DIPG patients who were enrolled on Stratum 2 and received at least one dose of APX005M are included in this analysis.
- reporting Status
- POSTED
- time Frame
- 1 year
- title
- Progression-free Survival for Stratum 2 (DIPG) Patients
- type
- SECONDARY
- unit Of Measure
- Percent probability
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice