TriangleNCT01524978 · OUTCOME
Percentage of Participants With Confirmed Clinical Benefit
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
- Up to approximately 3 years
What was measured
Included were participants with confirmed PR or CR or Stable Disease (SD) that had lasted at least 6 months according to RECIST v1.1 or confirmed CR, PR, VGPR, sCR or SD for at least 6 months according to IMWG criteria. RECIST v1.1: PR: \>/= 30% decrease in the sum of diameters of target lesions; CR: disappearance of all target lesions; SD: not meeting criteria for CR, PR or progressive disease (PD). IMWG: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \</= 5% plasma cells in bone marrow; PR: \>/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>/= 90% or to \<200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hour; sCR: CR plus normal FLC ratio and no clonal cells in bone marrow; SD: not meeting criteria for CR, VGPR, PR or PD.
Analysis population: ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.
Groups in this outcome
Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
Participants with NSCLC were treated with vemurafenib monotherapy.
Cohort 2: Ovarian Cancer - Vemurafenib
Participants with ovarian cancer were treated with vemurafenib monotherapy.
Cohort 3a: Colorectal Cancer - Vemurafenib
Participants with colorectal cancer were treated with vemurafenib monotherapy.
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
Cohort 4: Cholangiocarcinoma - Vemurafenib
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
Cohort 6: Multiple Myeloma - Vemurafenib
Participants with multiple myeloma were treated with vemurafenib monotherapy.
Cohort 7a: ECD/LCH - Vemurafenib
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
Cohort 7d: Early Stage Astrocytoma - Vemurafenib
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
| Group | Source count |
|---|---|
| Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib | 62 |
| Cohort 2: Ovarian Cancer - Vemurafenib | 4 |
| Cohort 3a: Colorectal Cancer - Vemurafenib | 10 |
| Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | 27 |
| Cohort 4: Cholangiocarcinoma - Vemurafenib | 9 |
| Cohort 6: Multiple Myeloma - Vemurafenib | 9 |
| Cohort 7a: ECD/LCH - Vemurafenib | 26 |
| Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib | 12 |
| Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | 12 |
| Cohort 7d: Early Stage Astrocytoma - Vemurafenib | 9 |
| Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib | 28 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib | 48.4 | Not reported | 35.50 | 61.44 | Not reported |
| Cohort 2: Ovarian Cancer - Vemurafenib | 50.0 | Not reported | 6.76 | 93.24 | Not reported |
| Cohort 3a: Colorectal Cancer - Vemurafenib | 0 | Not reported | NA | NA | N/A=NE=not estimable, because of insufficient number of participants with events |
| Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | 18.5 | Not reported | 6.30 | 38.08 | Not reported |
| Cohort 4: Cholangiocarcinoma - Vemurafenib | 44.4 | Not reported | 13.70 | 78.80 | Not reported |
| Cohort 6: Multiple Myeloma - Vemurafenib | 22.2 | Not reported | 2.81 | 60.01 | Not reported |
| Cohort 7a: ECD/LCH - Vemurafenib | 76.9 | Not reported | 56.35 | 91.03 | Not reported |
| Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib | 25.0 | Not reported | 5.49 | 57.19 | Not reported |
| Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | 33.3 | Not reported | 9.92 | 65.11 | Not reported |
| Cohort 7d: Early Stage Astrocytoma - Vemurafenib | 44.4 | Not reported | 13.70 | 78.80 | Not reported |
| Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib | 17.9 | Not reported | 6.06 | 36.89 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 35.50
- upper Limit
- 61.44
- value
- 48.4
- group Id
- OG001
- lower Limit
- 6.76
- upper Limit
- 93.24
- value
- 50.0
- comment
- N/A=NE=not estimable, because of insufficient number of participants with events
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- group Id
- OG003
- lower Limit
- 6.30
- upper Limit
- 38.08
- value
- 18.5
- group Id
- OG004
- lower Limit
- 13.70
- upper Limit
- 78.80
- value
- 44.4
- group Id
- OG005
- lower Limit
- 2.81
- upper Limit
- 60.01
- value
- 22.2
- group Id
- OG006
- lower Limit
- 56.35
- upper Limit
- 91.03
- value
- 76.9
- group Id
- OG007
- lower Limit
- 5.49
- upper Limit
- 57.19
- value
- 25.0
- group Id
- OG008
- lower Limit
- 9.92
- upper Limit
- 65.11
- value
- 33.3
- group Id
- OG009
- lower Limit
- 13.70
- upper Limit
- 78.80
- value
- 44.4
- group Id
- OG010
- lower Limit
- 6.06
- upper Limit
- 36.89
- value
- 17.9
- denoms
- counts
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 27
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 26
- group Id
- OG007
- value
- 12
- group Id
- OG008
- value
- 12
- group Id
- OG009
- value
- 9
- group Id
- OG010
- value
- 28
- units
- Participants
- description
- Included were participants with confirmed PR or CR or Stable Disease (SD) that had lasted at least 6 months according to RECIST v1.1 or confirmed CR, PR, VGPR, sCR or SD for at least 6 months according to IMWG criteria. RECIST v1.1: PR: \>/= 30% decrease in the sum of diameters of target lesions; CR: disappearance of all target lesions; SD: not meeting criteria for CR, PR or progressive disease (PD). IMWG: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \</= 5% plasma cells in bone marrow; PR: \>/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>/= 90% or to \<200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hour; sCR: CR plus normal FLC ratio and no clonal cells in bone marrow; SD: not meeting criteria for CR, VGPR, PR or PD.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with NSCLC were treated with vemurafenib monotherapy.
- id
- OG000
- title
- Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
- description
- Participants with ovarian cancer were treated with vemurafenib monotherapy.
- id
- OG001
- title
- Cohort 2: Ovarian Cancer - Vemurafenib
- description
- Participants with colorectal cancer were treated with vemurafenib monotherapy.
- id
- OG002
- title
- Cohort 3a: Colorectal Cancer - Vemurafenib
- description
- Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
- id
- OG003
- title
- Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
- description
- Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
- id
- OG004
- title
- Cohort 4: Cholangiocarcinoma - Vemurafenib
- description
- Participants with multiple myeloma were treated with vemurafenib monotherapy.
- id
- OG005
- title
- Cohort 6: Multiple Myeloma - Vemurafenib
- description
- Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
- id
- OG006
- title
- Cohort 7a: ECD/LCH - Vemurafenib
- description
- Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
- id
- OG007
- title
- Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
- description
- Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
- id
- OG008
- title
- Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
- description
- Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
- id
- OG009
- title
- Cohort 7d: Early Stage Astrocytoma - Vemurafenib
- description
- Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
- id
- OG010
- title
- Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
- param Type
- NUMBER
- population Description
- ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.
- reporting Status
- POSTED
- time Frame
- Up to approximately 3 years
- title
- Percentage of Participants With Confirmed Clinical Benefit
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice