TriangleNCT03389802 · OUTCOME
Overall Response Rate 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
- percentage
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 2 years
What was measured
Complete or partial responses were considered responses. Response was evaluated by imaging or clinical progression. The response rate (percentage of participants with responses) is reported with a 95% Blyth-Still-Casella confidence interval. Response rates are reported separately by dose level.
Analysis population: Stratum 2 patients with measurable disease present at baseline who received at least one dose of therapy and had their disease re-evaluated were considered evaluable for objective response. Two participants were considered not evaluable as they did not have their disease re-evaluated.
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 | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 2, Dose Level 2 | 0 | Not reported | 0.0 | 40.2 | Not reported |
| Stratum 2, Dose Level 3 | 0 | Not reported | 0.0 | 63.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 40.2
- value
- 0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 63.2
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- Complete or partial responses were considered responses. Response was evaluated by imaging or clinical progression. The response rate (percentage of participants with responses) is reported with a 95% Blyth-Still-Casella confidence interval. Response rates are reported separately by dose level.
- 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
- Stratum 2 patients with measurable disease present at baseline who received at least one dose of therapy and had their disease re-evaluated were considered evaluable for objective response. Two participants were considered not evaluable as they did not have their disease re-evaluated.
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Overall Response Rate for Stratum 2 (DIPG) Patients
- type
- SECONDARY
- unit Of Measure
- percentage
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice