NCT02039947 · OUTCOME
Overall Response (OR) 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
the number of subjects with a confirmed overall Complete response (CR) or Partial response (PR) by investigator assessment using the Response evaluation criteria in solid tumors (RECIST 1.1 criteria). To determine the overall response, all target and non-target lesions will be assessed using modified RECIST 1.1 criteria.
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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A | 45 | Not reported | Not reported | Not reported | Not reported |
| Cohort B | 9 | Not reported | Not reported | Not reported | Not reported |
| Cohort C | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort D | 11 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 11
- 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
- the number of subjects with a confirmed overall Complete response (CR) or Partial response (PR) by investigator assessment using the Response evaluation criteria in solid tumors (RECIST 1.1 criteria). To determine the overall response, all target and non-target lesions will be assessed using modified RECIST 1.1 criteria.
- 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
- Overall Response (OR) 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
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