TriangleNCT01885195 · OUTCOME
ORR for Hematologic Tumors: Multiple Myeloma
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 the start of the treatment until disease progression (maximum up to 19.4 months)
What was measured
ORR: percentage of participants with sCR, CR, VGPR or PR. For hematologic tumors (multiple myeloma), sCR: negative immunofixation on the serum, urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; CR: CR: negative immunofixation on the serum, urine, disappearance of any soft tissue, plasmacytomas and \<5% plasma cells in bone marrow; VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis or greater than equal to \>=90% reduction in serum M-component plus urine M-component \<100 mg per 24hour (hr); PR: \>50% reduction of serum M-protein and reduction in 24 hr urinary M-protein by \>90% or to \<200 mg/24 hr.
Analysis population: Full analysis set included all the participants who had received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Groups in this outcome
Binimetinib (MEK162)
Participants received an oral dose of 45 mg of binimetinib tablets (3 tablets of 15 mg) twice daily in each cycle starting from Cycle 1 Day 1 (1 cycle =28 days) until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason. Maximum treatment exposure was approximately of 19.4 months.
| Group | Source count |
|---|---|
| Binimetinib (MEK162) | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Binimetinib (MEK162) | 33.3 | Not reported | 0.8 | 90.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.8
- upper Limit
- 90.6
- value
- 33.3
- denoms
- counts
- group Id
- OG000
- value
- 3
- units
- Participants
- description
- ORR: percentage of participants with sCR, CR, VGPR or PR. For hematologic tumors (multiple myeloma), sCR: negative immunofixation on the serum, urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; CR: CR: negative immunofixation on the serum, urine, disappearance of any soft tissue, plasmacytomas and \<5% plasma cells in bone marrow; VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis or greater than equal to \>=90% reduction in serum M-component plus urine M-component \<100 mg per 24hour (hr); PR: \>50% reduction of serum M-protein and reduction in 24 hr urinary M-protein by \>90% or to \<200 mg/24 hr.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received an oral dose of 45 mg of binimetinib tablets (3 tablets of 15 mg) twice daily in each cycle starting from Cycle 1 Day 1 (1 cycle =28 days) until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason. Maximum treatment exposure was approximately of 19.4 months.
- id
- OG000
- title
- Binimetinib (MEK162)
- param Type
- NUMBER
- population Description
- Full analysis set included all the participants who had received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From the start of the treatment until disease progression (maximum up to 19.4 months)
- title
- ORR for Hematologic Tumors: Multiple Myeloma
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice