TriangleNCT02034110 · OUTCOME
Duration of Response (DoR) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
What was measured
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
Analysis population: ITT/Evaluable population - Primary analysis cohort. Only responders were included in the analysis.
Groups in this outcome
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
| Group | Source count |
|---|---|
| Low Grade (WHO G1/G2) Glioma (LGG) | 9 |
Reported measurements
Investigator assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low Grade (WHO G1/G2) Glioma (LGG) | NA | Not reported | 24.1 | NA | Not estimable due to insufficient events observed |
Independent radiology review
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low Grade (WHO G1/G2) Glioma (LGG) | 84.3 | Not reported | 16.4 | NA | Not estimable due to insufficient events observed |
Complete source fields
- classes
- categories
- measurements
- comment
- Not estimable due to insufficient events observed
- group Id
- OG000
- lower Limit
- 24.1
- upper Limit
- NA
- value
- NA
- title
- Investigator assessment
- categories
- measurements
- comment
- Not estimable due to insufficient events observed
- group Id
- OG000
- lower Limit
- 16.4
- upper Limit
- NA
- value
- 84.3
- title
- Independent radiology review
- denoms
- counts
- group Id
- OG000
- value
- 9
- units
- Participants
- description
- For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
- id
- OG000
- title
- Low Grade (WHO G1/G2) Glioma (LGG)
- param Type
- MEDIAN
- population Description
- ITT/Evaluable population - Primary analysis cohort. Only responders were included in the analysis.
- reporting Status
- POSTED
- time Frame
- From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
- title
- Duration of Response (DoR) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
- type
- SECONDARY
- unit Of Measure
- Weeks
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice