TriangleNCT02034110 · OUTCOME
Overall Response Rate (ORR) in the Multiple Myeloma (MM) Cohort
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
What was measured
Overall Response Rate (ORR) was defined as the percentage of participants with stringent complete response (sCR), CR, PR, very good partial response (VGPR) by investigator assessment as defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma. Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population.
Analysis population: ITT/Evaluable population - Primary analysis cohort
Groups in this outcome
Multiple Myeloma (MM)
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 |
|---|---|
| Multiple Myeloma (MM) | 10 |
Reported measurements
Investigator assessment @ up to 78 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Multiple Myeloma (MM) | 50 | Not reported | 18.7 | 81.3 | Not reported |
Investigator assessment @ up to 92 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Multiple Myeloma (MM) | 50 | Not reported | 18.7 | 81.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.7
- upper Limit
- 81.3
- value
- 50
- title
- Investigator assessment @ up to 78 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.7
- upper Limit
- 81.3
- value
- 50
- title
- Investigator assessment @ up to 92 months
- denoms
- counts
- group Id
- OG000
- value
- 10
- units
- Participants
- description
- Overall Response Rate (ORR) was defined as the percentage of participants with stringent complete response (sCR), CR, PR, very good partial response (VGPR) by investigator assessment as defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma. Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population.
- 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
- Multiple Myeloma (MM)
- param Type
- NUMBER
- population Description
- ITT/Evaluable population - Primary analysis cohort
- reporting Status
- POSTED
- time Frame
- From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
- title
- Overall Response Rate (ORR) in the Multiple Myeloma (MM) Cohort
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice