TriangleNCT02039947 · OUTCOME
Disease Control for Intracranial, Extracranial and Overall Response for Each Cohort
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Number of participants
- Interval / dispersion
- Not reported
- Time frame
- Approximately 2 years
What was measured
Disease Control rate is defined as the percentage of subjects achieving a confirmed intracranial/extracranial/overall CR or PR or SD or Non-CR/Non-PD. This is based on investigator-assessed response. No hypothesis testing completed for cohort A, B,C and D
Analysis population: All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population
Groups in this outcome
Cohort A
Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
Cohort B
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
Cohort C
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
Cohort D
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
| Group | Source count |
|---|---|
| Cohort A | 76 |
| Cohort B | 16 |
| Cohort C | 16 |
| Cohort D | 17 |
Reported measurements
Intracranial
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A | 59 | Not reported | Not reported | Not reported | Not reported |
| Cohort B | 14 | Not reported | Not reported | Not reported | Not reported |
| Cohort C | 12 | Not reported | Not reported | Not reported | Not reported |
| Cohort D | 15 | Not reported | Not reported | Not reported | Not reported |
Extra cranial
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A | 60 | Not reported | Not reported | Not reported | Not reported |
| Cohort B | 11 | Not reported | Not reported | Not reported | Not reported |
| Cohort C | 15 | Not reported | Not reported | Not reported | Not reported |
| Cohort D | 11 | Not reported | Not reported | Not reported | Not reported |
Overall rate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A | 60 | Not reported | Not reported | Not reported | Not reported |
| Cohort B | 14 | Not reported | Not reported | Not reported | Not reported |
| Cohort C | 12 | Not reported | Not reported | Not reported | Not reported |
| Cohort D | 15 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 15
- title
- Intracranial
- categories
- measurements
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 11
- title
- Extra cranial
- categories
- measurements
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 15
- title
- Overall rate
- denoms
- counts
- group Id
- OG000
- value
- 76
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 16
- group Id
- OG003
- value
- 17
- units
- Participants
- description
- Disease Control rate is defined as the percentage of subjects achieving a confirmed intracranial/extracranial/overall CR or PR or SD or Non-CR/Non-PD. This is based on investigator-assessed response. No hypothesis testing completed for cohort A, B,C and D
- groups
- description
- Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
- id
- OG000
- title
- Cohort A
- description
- Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
- id
- OG001
- title
- Cohort B
- description
- Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
- id
- OG002
- title
- Cohort C
- description
- Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
- id
- OG003
- title
- Cohort D
- param Type
- NUMBER
- population Description
- All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population
- reporting Status
- POSTED
- time Frame
- Approximately 2 years
- title
- Disease Control for Intracranial, Extracranial and Overall Response for Each Cohort
- type
- SECONDARY
- unit Of Measure
- Number of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice