TriangleNCT03389802 · OUTCOME
Tumor Mutation Burden Based on RNA Sequencing of Tumor Tissue
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- mutations per megabase
- Interval / dispersion
- Standard Deviation
- Time frame
- Day 0 of treatment
What was measured
Tumor mutation burden was defined as the number of somatic mutations per megabase. Average tumor mutation burden was reported with a standard deviation. When only one patient was analyzed, the standard deviation was reported as 0 rather than undefined.
Analysis population: No Stratum 2 patients were included in this analysis.
Groups in this outcome
Stratum 1, Dose Level 1
Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.1 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Stratum 1, Dose Level 2
Patients with recurrent or refractory primary malignant CNS tumors 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 1, Dose Level 3
Patients with recurrent or refractory primary malignant CNS tumors 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.
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 1, Dose Level 1 | 2 |
| Stratum 1, Dose Level 2 | 3 |
| Stratum 1, Dose Level 3 | 11 |
| Stratum 2, Dose Level 2 | 0 |
| Stratum 2, Dose Level 3 | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1, Dose Level 1 | 3.15 | 0.92 | Not reported | Not reported | Not reported |
| Stratum 1, Dose Level 2 | 3.33 | 0.32 | Not reported | Not reported | Not reported |
| Stratum 1, Dose Level 3 | 3.26 | 1.35 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.92
- value
- 3.15
- group Id
- OG001
- spread
- 0.32
- value
- 3.33
- group Id
- OG002
- spread
- 1.35
- value
- 3.26
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- units
- Participants
- description
- Tumor mutation burden was defined as the number of somatic mutations per megabase. Average tumor mutation burden was reported with a standard deviation. When only one patient was analyzed, the standard deviation was reported as 0 rather than undefined.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.1 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
- id
- OG000
- title
- Stratum 1, Dose Level 1
- description
- Patients with recurrent or refractory primary malignant CNS tumors 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
- OG001
- title
- Stratum 1, Dose Level 2
- description
- Patients with recurrent or refractory primary malignant CNS tumors 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
- OG002
- title
- Stratum 1, Dose Level 3
- 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
- OG003
- 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
- OG004
- title
- Stratum 2, Dose Level 3
- param Type
- MEAN
- population Description
- No Stratum 2 patients were included in this analysis.
- reporting Status
- POSTED
- time Frame
- Day 0 of treatment
- title
- Tumor Mutation Burden Based on RNA Sequencing of Tumor Tissue
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- mutations per megabase
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice