Trial Outcomes & Findings for A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers (NCT NCT01524978)
NCT ID: NCT01524978
Last Updated: 2017-11-20
Results Overview
Confirmed BORR: percentage of participants with an objective response (OR) (complete response \[CR\], partial response \[PR\], stringent CR \[sCR\] or very good PR \[VGPR\]) on 2 occasions \>/= 4 weeks apart as assessed by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. or International Myeloma Working Group (IMWG) criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: \>/= 30% decrease in the sum of diameters of target lesions. 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 free light chain (FLC) ratio and no clonal cells in bone marrow.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
208 participants
Primary outcome timeframe
Up to approximately 3 years
Results posted on
2017-11-20
Participant Flow
One participant with breast cancer was screened shortly after Cohort 5 (Breast Cancer) had been closed. This participant was allowed to enter the study in Cohort 7: Other BRAF V600-positive tumors. For analysis purposes Cohort 7 was split into sub-cohorts for indications with sufficient participants.
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
62
|
4
|
10
|
27
|
9
|
9
|
26
|
12
|
12
|
9
|
28
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
62
|
4
|
10
|
27
|
9
|
9
|
26
|
12
|
12
|
9
|
28
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Other
|
16
|
2
|
1
|
2
|
1
|
3
|
17
|
1
|
2
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
12
|
0
|
1
|
1
|
3
|
1
|
6
|
2
|
4
|
0
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
0
|
1
|
1
|
2
|
0
|
1
|
1
|
1
|
|
Overall Study
Death
|
34
|
2
|
5
|
24
|
4
|
4
|
1
|
9
|
5
|
6
|
17
|
Baseline Characteristics
A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers
Baseline characteristics by cohort
| Measure |
Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
n=62 Participants
Participants with NSCLC were treated with vemurafenib monotherapy.
|
Cohort 2: Ovarian Cancer - Vemurafenib
n=4 Participants
Participants with ovarian cancer were treated with vemurafenib monotherapy.
|
Cohort 3a: Colorectal Cancer - Vemurafenib
n=10 Participants
Participants with colorectal cancer were treated with vemurafenib monotherapy.
|
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
n=27 Participants
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
|
Cohort 4: Cholangiocarcinoma - Vemurafenib
n=9 Participants
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
|
Cohort 6: Multiple Myeloma - Vemurafenib
n=9 Participants
Participants with multiple myeloma were treated with vemurafenib monotherapy.
|
Cohort 7a: ECD/LCH - Vemurafenib
n=26 Participants
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
|
Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
n=12 Participants
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
|
Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
n=12 Participants
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7d: Early Stage Astrocytoma - Vemurafenib
n=9 Participants
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
n=28 Participants
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
45.8 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
57.3 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
64.3 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
53.2 years
STANDARD_DEVIATION 9.7 • n=21 Participants
|
62.1 years
STANDARD_DEVIATION 4.3 • n=10 Participants
|
60.8 years
STANDARD_DEVIATION 13.3 • n=115 Participants
|
66.8 years
STANDARD_DEVIATION 9.2 • n=24 Participants
|
41.6 years
STANDARD_DEVIATION 12.2 • n=42 Participants
|
34.3 years
STANDARD_DEVIATION 20.7 • n=42 Participants
|
53.7 years
STANDARD_DEVIATION 17.5 • n=42 Participants
|
59.0 years
STANDARD_DEVIATION 14.5 • n=42 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
111 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
9 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
97 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 3 yearsPopulation: ITT population included all participants enrolled in the study irrespective of whether they had received study drug or not.
Confirmed BORR: percentage of participants with an objective response (OR) (complete response \[CR\], partial response \[PR\], stringent CR \[sCR\] or very good PR \[VGPR\]) on 2 occasions \>/= 4 weeks apart as assessed by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. or International Myeloma Working Group (IMWG) criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: \>/= 30% decrease in the sum of diameters of target lesions. 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 free light chain (FLC) ratio and no clonal cells in bone marrow.
Outcome measures
| Measure |
Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
n=62 Participants
Participants with NSCLC were treated with vemurafenib monotherapy.
|
Cohort 2: Ovarian Cancer - Vemurafenib
n=4 Participants
Participants with ovarian cancer were treated with vemurafenib monotherapy.
|
Cohort 3a: Colorectal Cancer - Vemurafenib
n=10 Participants
Participants with colorectal cancer were treated with vemurafenib monotherapy.
|
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
n=27 Participants
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
|
Cohort 4: Cholangiocarcinoma - Vemurafenib
n=9 Participants
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
|
Cohort 6: Multiple Myeloma - Vemurafenib
n=9 Participants
Participants with multiple myeloma were treated with vemurafenib monotherapy.
|
Cohort 7a: ECD/LCH - Vemurafenib
n=26 Participants
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
|
Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
n=12 Participants
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
|
Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
n=12 Participants
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7d: Early Stage Astrocytoma - Vemurafenib
n=9 Participants
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
n=28 Participants
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Confirmed Best Overall Response Rate (BORR)
|
37.1 percentage of participants
Interval 25.16 to 50.31
|
50.0 percentage of participants
Interval 6.76 to 93.24
|
0 percentage of participants
Interval 0.0 to 30.85
|
7.4 percentage of participants
Interval 0.91 to 24.29
|
22.2 percentage of participants
Interval 2.81 to 60.01
|
22.2 percentage of participants
Interval 2.81 to 60.01
|
61.5 percentage of participants
Interval 40.57 to 79.77
|
25.0 percentage of participants
Interval 5.49 to 57.19
|
16.7 percentage of participants
Interval 2.09 to 48.41
|
33.3 percentage of participants
Interval 7.49 to 70.07
|
17.9 percentage of participants
Interval 6.06 to 36.89
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.
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.
Outcome measures
| Measure |
Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
n=62 Participants
Participants with NSCLC were treated with vemurafenib monotherapy.
|
Cohort 2: Ovarian Cancer - Vemurafenib
n=4 Participants
Participants with ovarian cancer were treated with vemurafenib monotherapy.
|
Cohort 3a: Colorectal Cancer - Vemurafenib
n=10 Participants
Participants with colorectal cancer were treated with vemurafenib monotherapy.
|
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
n=27 Participants
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
|
Cohort 4: Cholangiocarcinoma - Vemurafenib
n=9 Participants
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
|
Cohort 6: Multiple Myeloma - Vemurafenib
n=9 Participants
Participants with multiple myeloma were treated with vemurafenib monotherapy.
|
Cohort 7a: ECD/LCH - Vemurafenib
n=26 Participants
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
|
Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
n=12 Participants
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
|
Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
n=12 Participants
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7d: Early Stage Astrocytoma - Vemurafenib
n=9 Participants
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
n=28 Participants
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Confirmed Clinical Benefit
|
48.4 percentage of participants
Interval 35.5 to 61.44
|
50.0 percentage of participants
Interval 6.76 to 93.24
|
0 percentage of participants
N/A=NE=not estimable, because of insufficient number of participants with events
|
18.5 percentage of participants
Interval 6.3 to 38.08
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
22.2 percentage of participants
Interval 2.81 to 60.01
|
76.9 percentage of participants
Interval 56.35 to 91.03
|
25.0 percentage of participants
Interval 5.49 to 57.19
|
33.3 percentage of participants
Interval 9.92 to 65.11
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
17.9 percentage of participants
Interval 6.06 to 36.89
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.
ORR: percentage of participants with an objective response (OR) (CR, PR, sCR or VGPR) on 2 occasions \>/= 4 weeks apart as assessed by the Investigator using RECIST v1.1. or IMWG criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: \>/= 30% decrease in the sum of diameters of target lesions. 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.
Outcome measures
| Measure |
Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
n=62 Participants
Participants with NSCLC were treated with vemurafenib monotherapy.
|
Cohort 2: Ovarian Cancer - Vemurafenib
n=4 Participants
Participants with ovarian cancer were treated with vemurafenib monotherapy.
|
Cohort 3a: Colorectal Cancer - Vemurafenib
n=10 Participants
Participants with colorectal cancer were treated with vemurafenib monotherapy.
|
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
n=27 Participants
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
|
Cohort 4: Cholangiocarcinoma - Vemurafenib
n=9 Participants
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
|
Cohort 6: Multiple Myeloma - Vemurafenib
n=9 Participants
Participants with multiple myeloma were treated with vemurafenib monotherapy.
|
Cohort 7a: ECD/LCH - Vemurafenib
n=26 Participants
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
|
Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
n=12 Participants
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
|
Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
n=12 Participants
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7d: Early Stage Astrocytoma - Vemurafenib
n=9 Participants
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
n=28 Participants
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
CR
|
0 percentage of participants
Interval 0.0 to 5.78
|
0 percentage of participants
Interval 0.0 to 60.24
|
0 percentage of participants
Interval 0.0 to 30.85
|
0 percentage of participants
Interval 0.0 to 12.77
|
0 percentage of participants
Interval 0.0 to 33.63
|
0 percentage of participants
Interval 0.0 to 33.63
|
7.7 percentage of participants
Interval 0.95 to 25.13
|
8.3 percentage of participants
Interval 0.21 to 38.48
|
8.3 percentage of participants
Interval 0.21 to 38.48
|
0 percentage of participants
Interval 0.0 to 33.63
|
3.6 percentage of participants
Interval 0.09 to 18.35
|
|
Overall Response Rate (ORR)
PR
|
37.1 percentage of participants
Interval 25.16 to 50.31
|
50.0 percentage of participants
Interval 6.76 to 93.24
|
0 percentage of participants
Interval 0.0 to 30.85
|
7.4 percentage of participants
Interval 0.91 to 24.29
|
22.2 percentage of participants
Interval 2.81 to 60.01
|
11.1 percentage of participants
Interval 0.28 to 48.25
|
53.8 percentage of participants
Interval 33.37 to 73.41
|
16.7 percentage of participants
Interval 2.09 to 48.41
|
8.3 percentage of participants
Interval 0.21 to 38.48
|
33.3 percentage of participants
Interval 7.49 to 70.07
|
14.3 percentage of participants
Interval 4.03 to 32.67
|
|
Overall Response Rate (ORR)
VGPR
|
NA percentage of participants
N/A= VGPR data only collected in multiple myeloma cohort
|
NA percentage of participants
N/A= VGPR data only collected in multiple myeloma cohort
|
NA percentage of participants
N/A= VGPR data only collected in multiple myeloma cohort
|
NA percentage of participants
N/A= VGPR data only collected in multiple myeloma cohort
|
NA percentage of participants
N/A= VGPR data only collected in multiple myeloma cohort
|
11.1 percentage of participants
Interval 0.28 to 48.25
|
NA percentage of participants
N/A= VGPR data only collected in multiple myeloma cohort
|
NA percentage of participants
N/A= VGPR data only collected in multiple myeloma cohort
|
NA percentage of participants
N/A= VGPR data only collected in multiple myeloma cohort
|
NA percentage of participants
N/A= VGPR data only collected in multiple myeloma cohort
|
NA percentage of participants
N/A= VGPR data only collected in multiple myeloma cohort
|
|
Overall Response Rate (ORR)
sCR
|
NA percentage of participants
N/A= sCR data only collected in multiple myeloma cohort
|
NA percentage of participants
N/A= sCR data only collected in multiple myeloma cohort
|
NA percentage of participants
N/A= sCR data only collected in multiple myeloma cohort
|
NA percentage of participants
N/A= sCR data only collected in multiple myeloma cohort
|
NA percentage of participants
N/A= sCR data only collected in multiple myeloma cohort
|
0 percentage of participants
Interval 0.0 to 33.63
|
NA percentage of participants
N/A= sCR data only collected in multiple myeloma cohort
|
NA percentage of participants
N/A= sCR data only collected in multiple myeloma cohort
|
NA percentage of participants
N/A= sCR data only collected in multiple myeloma cohort
|
NA percentage of participants
N/A= sCR data only collected in multiple myeloma cohort
|
NA percentage of participants
N/A= sCR data only collected in multiple myeloma cohort
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.
DOR was defined as the period from the date of initial PR or CR for solid tumors according to RECISTv1.1 and CR, PR, VGPR or sCR for multiple myeloma according to IMWG criteria, until the date of PD or death from any cause. RECIST v1.1: PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. IMWG: PD: increase of \>/= 25% from lowest response value in serum or urine M-protein or bone marrow plasma cell percentage or development of new or increase in size of bone lesions or soft tissue plasmacytomas.
Outcome measures
| Measure |
Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
n=62 Participants
Participants with NSCLC were treated with vemurafenib monotherapy.
|
Cohort 2: Ovarian Cancer - Vemurafenib
n=4 Participants
Participants with ovarian cancer were treated with vemurafenib monotherapy.
|
Cohort 3a: Colorectal Cancer - Vemurafenib
n=10 Participants
Participants with colorectal cancer were treated with vemurafenib monotherapy.
|
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
n=27 Participants
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
|
Cohort 4: Cholangiocarcinoma - Vemurafenib
n=9 Participants
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
|
Cohort 6: Multiple Myeloma - Vemurafenib
n=9 Participants
Participants with multiple myeloma were treated with vemurafenib monotherapy.
|
Cohort 7a: ECD/LCH - Vemurafenib
n=26 Participants
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
|
Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
n=12 Participants
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
|
Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
n=12 Participants
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7d: Early Stage Astrocytoma - Vemurafenib
n=9 Participants
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
n=28 Participants
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
7.16 months
Interval 5.49 to 18.43
|
8.16 months
Interval 3.88 to 12.45
|
NA months
N/A=NE=not estimable, because of insufficient number of participants with events
|
6.54 months
Interval 5.68 to 7.39
|
12.86 months
Interval 3.58 to 22.14
|
NA months
N/A=NE=not estimable, because of insufficient number of participants with events
|
NA months
N/A=NE=not estimable, because of insufficient number of participants with events
|
9.95 months
Interval 8.31 to 30.98
|
NA months
Interval 13.08 to
N/A=NE=not estimable, because of insufficient number of participants with events
|
3.42 months
Interval 2.4 to 7.49
|
9.92 months
Interval 3.48 to 21.22
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.
Time to response was defined as the time from the first day of study treatment to the date of first CR, or PR for solid tumors according to RECISTv1.1 and CR, PR, VGPR or sCR for multiple myeloma according to IMWG criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of diameters of target lesions. IMWG criteria: CR: negative immunofixation on serum and urine and 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.
Outcome measures
| Measure |
Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
n=62 Participants
Participants with NSCLC were treated with vemurafenib monotherapy.
|
Cohort 2: Ovarian Cancer - Vemurafenib
n=4 Participants
Participants with ovarian cancer were treated with vemurafenib monotherapy.
|
Cohort 3a: Colorectal Cancer - Vemurafenib
n=10 Participants
Participants with colorectal cancer were treated with vemurafenib monotherapy.
|
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
n=27 Participants
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
|
Cohort 4: Cholangiocarcinoma - Vemurafenib
n=9 Participants
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
|
Cohort 6: Multiple Myeloma - Vemurafenib
n=9 Participants
Participants with multiple myeloma were treated with vemurafenib monotherapy.
|
Cohort 7a: ECD/LCH - Vemurafenib
n=26 Participants
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
|
Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
n=12 Participants
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
|
Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
n=12 Participants
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7d: Early Stage Astrocytoma - Vemurafenib
n=9 Participants
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
n=28 Participants
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Response
|
7.26 months
Interval 3.68 to
N/A=NE=not estimable due to insufficient number of participants with events
|
NA months
Interval 1.64 to
N/A=NE=not estimable due to insufficient number of participants with events
|
NA months
N/A=NE=not estimable due to insufficient number of participants with events
|
NA months
N/A=NE=not estimable due to insufficient number of participants with events
|
NA months
Interval 3.52 to
N/A=NE=not estimable due to insufficient number of participants with events
|
5.75 months
N/A=NE=not estimable due to insufficient number of participants with events
|
5.49 months
Interval 3.68 to 13.73
|
NA months
Interval 1.68 to
N/A=NE=not estimable due to insufficient number of participants with events
|
NA months
Interval 1.74 to
N/A=NE=not estimable due to insufficient number of participants with events
|
NA months
Interval 2.33 to
N/A=NE=not estimable due to insufficient number of participants with events
|
NA months
Interval 3.68 to
N/A=NE=not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.
TTP was defined as time from the first day of study treatment to the first occurrence of progressive disease (PD). RECIST v1.1: PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. IMWG: PD: increase of \>/= 25% from lowest response value in serum or urine M-protein or bone marrow plasma cell percentage or development of new or increase in size of bone lesions or soft tissue plasmacytomas.
Outcome measures
| Measure |
Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
n=62 Participants
Participants with NSCLC were treated with vemurafenib monotherapy.
|
Cohort 2: Ovarian Cancer - Vemurafenib
n=4 Participants
Participants with ovarian cancer were treated with vemurafenib monotherapy.
|
Cohort 3a: Colorectal Cancer - Vemurafenib
n=10 Participants
Participants with colorectal cancer were treated with vemurafenib monotherapy.
|
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
n=27 Participants
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
|
Cohort 4: Cholangiocarcinoma - Vemurafenib
n=9 Participants
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
|
Cohort 6: Multiple Myeloma - Vemurafenib
n=9 Participants
Participants with multiple myeloma were treated with vemurafenib monotherapy.
|
Cohort 7a: ECD/LCH - Vemurafenib
n=26 Participants
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
|
Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
n=12 Participants
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
|
Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
n=12 Participants
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7d: Early Stage Astrocytoma - Vemurafenib
n=9 Participants
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
n=28 Participants
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Tumor Progression (TTP)
|
7.33 months
Interval 5.29 to 9.66
|
6.44 months
Interval 1.87 to 14.29
|
3.88 months
Interval 1.84 to 5.52
|
3.68 months
Interval 3.45 to 5.39
|
3.02 months
Interval 1.64 to 9.0
|
4.63 months
Interval 2.89 to
N/A=NE=not estimable due to insufficient number of participants with events
|
NA months
N/A=NE=not estimable due to insufficient number of participants with events
|
2.83 months
Interval 1.77 to 5.49
|
5.62 months
Interval 1.81 to 14.85
|
5.36 months
Interval 3.02 to 9.1
|
3.65 months
Interval 1.68 to 5.75
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.
PFS was defined as the time from the first day of study treatment, until the first documented PD or death from any cause, whichever occurs first. RECIST v1.1: PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. IMWG criteria: PD: increase of \>/= 25% from lowest response value in serum or urine M-protein or bone marrow plasma cell percentage or development of new or increase in size of bone lesions or soft tissue plasmacytomas.
Outcome measures
| Measure |
Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
n=62 Participants
Participants with NSCLC were treated with vemurafenib monotherapy.
|
Cohort 2: Ovarian Cancer - Vemurafenib
n=4 Participants
Participants with ovarian cancer were treated with vemurafenib monotherapy.
|
Cohort 3a: Colorectal Cancer - Vemurafenib
n=10 Participants
Participants with colorectal cancer were treated with vemurafenib monotherapy.
|
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
n=27 Participants
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
|
Cohort 4: Cholangiocarcinoma - Vemurafenib
n=9 Participants
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
|
Cohort 6: Multiple Myeloma - Vemurafenib
n=9 Participants
Participants with multiple myeloma were treated with vemurafenib monotherapy.
|
Cohort 7a: ECD/LCH - Vemurafenib
n=26 Participants
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
|
Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
n=12 Participants
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
|
Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
n=12 Participants
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7d: Early Stage Astrocytoma - Vemurafenib
n=9 Participants
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
n=28 Participants
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
6.51 months
Interval 5.16 to 8.97
|
6.44 months
Interval 1.87 to 14.29
|
3.88 months
Interval 1.84 to 5.52
|
3.68 months
Interval 1.81 to 5.39
|
3.02 months
Interval 1.64 to 9.0
|
4.63 months
Interval 2.89 to
N/A=NE=not estimable due to insufficient number of participants with events
|
NA months
N/A=NE=not estimable due to insufficient number of participants with events
|
2.83 months
Interval 1.77 to 5.49
|
9.59 months
Interval 1.81 to 14.78
|
5.26 months
Interval 3.02 to 5.72
|
3.12 months
Interval 1.64 to 5.55
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.
OS was defined as time between the first day of study treatment and date of death of any cause.
Outcome measures
| Measure |
Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
n=62 Participants
Participants with NSCLC were treated with vemurafenib monotherapy.
|
Cohort 2: Ovarian Cancer - Vemurafenib
n=4 Participants
Participants with ovarian cancer were treated with vemurafenib monotherapy.
|
Cohort 3a: Colorectal Cancer - Vemurafenib
n=10 Participants
Participants with colorectal cancer were treated with vemurafenib monotherapy.
|
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
n=27 Participants
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
|
Cohort 4: Cholangiocarcinoma - Vemurafenib
n=9 Participants
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
|
Cohort 6: Multiple Myeloma - Vemurafenib
n=9 Participants
Participants with multiple myeloma were treated with vemurafenib monotherapy.
|
Cohort 7a: ECD/LCH - Vemurafenib
n=26 Participants
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
|
Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
n=12 Participants
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
|
Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
n=12 Participants
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7d: Early Stage Astrocytoma - Vemurafenib
n=9 Participants
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
n=28 Participants
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
15.38 months
Interval 9.56 to 22.77
|
NA months
Interval 2.56 to
N/A=NE=not estimable due to insufficient number of participants with events
|
9.30 months
Interval 7.82 to 12.88
|
7.16 months
Interval 5.49 to 11.73
|
17.94 months
Interval 11.2 to
N/A=NE=not estimable due to insufficient number of participants with events
|
24.54 months
Interval 4.96 to
N/A=NE=not estimable due to insufficient number of participants with events
|
NA months
N/A=NE=not estimable due to insufficient number of participants with events
|
5.88 months
Interval 2.17 to 16.79
|
40.11 months
Interval 9.59 to 40.11
|
12.75 months
Interval 6.7 to
N/A=NE=not estimable due to insufficient number of participants with events
|
11.56 months
Interval 3.71 to 28.16
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: All participants from Cohort 3b who received at least one dose of study medication.
Cohort 3b included participants with colorectal cancer treated with escalating doses of vemurafenib and cetuximab. The escalating doses were as follows: Dose Level 1: 720 milligrams (mg) of vemurafenib orally twice daily starting on Day 2 of Cycle 1 and 300 milligrams per square meter (mg/m\^2) loading dose of cetuximab by infusion and then 200 mg/m\^2 weekly; Dose Level 2: 720 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m\^2 loading dose of cetuximab and then 250 mg/m\^2 weekly; Dose Level 3: 960 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m\^2 loading dose of cetuximab and then 250 mg/m\^2 weekly. Reported here are the maximum tolerated doses for each vemurafenib and cetuximab.
Outcome measures
| Measure |
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
n=14 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose for Vemurafenib in Combination With Cetuximab
vemurafenib
|
—
|
—
|
—
|
960 milligrams (mg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Tolerated Dose for Vemurafenib in Combination With Cetuximab
cetuximab
|
—
|
—
|
—
|
400 milligrams (mg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: All participants from Cohort 3b who received at least one dose of study medication.
Cohort 3b included participants with colorectal cancer treated with escalating doses of vemurafenib and cetuximab. The escalating doses were as follows: Dose Level 1: 720 milligrams (mg) of vemurafenib orally twice daily starting on Day 2 of Cycle 1 and 300 milligrams per square meter (mg/m\^2) loading dose of cetuximab by infusion and then 200 mg/m\^2 weekly; Dose Level 2: 720 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m\^2 loading dose of cetuximab and then 250 mg/m\^2 weekly; Dose Level 3: 960 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m\^2 loading dose of cetuximab and then 250 mg/m\^2 weekly. Reported here are type and number of dose limited toxicities observed.
Outcome measures
| Measure |
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
n=14 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Dose-limiting Toxicities of Vemurafenib in Combination With Cetuximab
Grade 3 amylase increased
|
—
|
—
|
—
|
1 dose-limiting toxicities
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Dose-limiting Toxicities of Vemurafenib in Combination With Cetuximab
Grade 4 lipase increased
|
—
|
—
|
—
|
1 dose-limiting toxicities
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: The safety population included all participants who received at least one dose of study medication.
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
n=62 Participants
Participants with NSCLC were treated with vemurafenib monotherapy.
|
Cohort 2: Ovarian Cancer - Vemurafenib
n=4 Participants
Participants with ovarian cancer were treated with vemurafenib monotherapy.
|
Cohort 3a: Colorectal Cancer - Vemurafenib
n=10 Participants
Participants with colorectal cancer were treated with vemurafenib monotherapy.
|
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
n=27 Participants
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
|
Cohort 4: Cholangiocarcinoma - Vemurafenib
n=9 Participants
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
|
Cohort 6: Multiple Myeloma - Vemurafenib
n=9 Participants
Participants with multiple myeloma were treated with vemurafenib monotherapy.
|
Cohort 7a: ECD/LCH - Vemurafenib
n=26 Participants
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
|
Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
n=12 Participants
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
|
Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
n=12 Participants
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7d: Early Stage Astrocytoma - Vemurafenib
n=9 Participants
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
|
Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
n=28 Participants
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety: Percentage of Participants With Adverse Event
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
91.7 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
Adverse Events
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
Serious events: 11 serious events
Other events: 26 other events
Deaths: 0 deaths
Pooled Arm - Vemurafenib
Serious events: 91 serious events
Other events: 177 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
n=27 participants at risk
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
|
Pooled Arm - Vemurafenib
n=181 participants at risk
Participants with a variety of cancer types, who were treated with vemurafenib monotherapy, were combined into this arm.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
11.1%
3/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
13.8%
25/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
9.9%
18/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
3.7%
1/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
3.9%
7/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
3.7%
1/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
3.7%
1/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Subileus
|
3.7%
1/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
3.7%
1/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
3.7%
1/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
1.1%
2/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholestasis
|
3.7%
1/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
3.7%
1/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.7%
1/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.7%
1/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
2.2%
4/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Bladder dilatation
|
3.7%
1/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Obstructive uropathy
|
3.7%
1/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
3.7%
1/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
2.2%
4/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelomonocytic leukaemia
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraganglion neoplasm
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Sepsis
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
3.3%
6/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
2.8%
5/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Lung infection
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
2.2%
4/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
1.7%
3/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
1.1%
2/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Furuncle
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Septic shock
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
1.7%
3/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
1.7%
3/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
1.1%
2/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal dyspnoea
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Seizure
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
General disorders
Fatigue
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
1.1%
2/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
General disorders
Chest pain
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
General disorders
Hyperthermia
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
1.7%
3/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
1.1%
2/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
1.1%
2/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Dressler's syndrome
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
1.1%
2/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Pseudolymphoma
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Depression
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Investigations
Body temperature increased
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.55%
1/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
Other adverse events
| Measure |
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
n=27 participants at risk
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
|
Pooled Arm - Vemurafenib
n=181 participants at risk
Participants with a variety of cancer types, who were treated with vemurafenib monotherapy, were combined into this arm.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
3/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
16.6%
30/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
44.4%
12/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
6.6%
12/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.8%
4/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
18.5%
5/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
14.4%
26/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
48.1%
13/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
27.1%
49/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Flatulence
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
9/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
29.8%
54/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
14.8%
4/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
10.5%
19/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
29.6%
8/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
22.7%
41/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
General disorders
Asthenia
|
37.0%
10/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
21.5%
39/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
General disorders
Chest pain
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
General disorders
Chills
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
5.5%
10/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
General disorders
Fatigue
|
22.2%
6/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
33.1%
60/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
General disorders
Oedema peripheral
|
14.8%
4/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
11.6%
21/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
18.5%
5/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
14.4%
26/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Conjunctivitis
|
11.1%
3/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Folliculitis
|
11.1%
3/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
9.9%
18/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Oral candidiasis
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Rash pustular
|
11.1%
3/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Skin infection
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
3/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Sunburn
|
14.8%
4/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
12.2%
22/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Investigations
Amylase increased
|
22.2%
6/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
8.3%
15/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Investigations
Blood bilirubin increased
|
11.1%
3/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
5.5%
10/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Investigations
Electrocardiogram QT prolonged
|
14.8%
4/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
20.4%
37/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Investigations
Lipase increased
|
33.3%
9/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
5.5%
10/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Investigations
Lymphocyte count decreased
|
11.1%
3/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Investigations
Weight decreased
|
22.2%
6/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
11.0%
20/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
37.0%
10/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
27.6%
50/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
18.5%
5/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
9.9%
18/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
51.9%
14/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
43.6%
79/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.8%
4/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
9.9%
18/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
3/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
9.9%
18/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
7.2%
13/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
14.8%
4/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
22.7%
41/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
11.1%
3/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
19.9%
36/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
25.9%
7/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
27.6%
50/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
14.8%
4/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
14.4%
26/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
7.7%
14/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Depression
|
11.1%
3/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
5.5%
10/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Haematuria
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Micturition urgency
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
17.1%
31/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.5%
5/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
12.2%
22/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
14.8%
4/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
15.5%
28/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
31.5%
57/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
21.5%
39/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.9%
7/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
13.3%
24/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
14.8%
4/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
32.0%
58/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
18.5%
5/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
21.5%
39/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.5%
5/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
23.2%
42/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
37.0%
10/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
24.3%
44/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.1%
3/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
23.2%
42/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
7.4%
2/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
0.00%
0/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
11.1%
3/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
15.5%
28/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Eye disorders
Dry eye
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
6.1%
11/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
6.6%
12/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
7.7%
14/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
General disorders
Cyst
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
11.6%
21/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
General disorders
Xerosis
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
8.8%
16/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
6.1%
11/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
8.3%
15/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
6.1%
11/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
10.5%
19/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
7.7%
14/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
9.4%
17/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
13.3%
24/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
14.9%
27/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
9.9%
18/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
5.5%
10/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
9.9%
18/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
5.5%
10/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
18.2%
33/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Milia
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
8.8%
16/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
26.5%
48/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
7.2%
13/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
11.6%
21/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/27 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
6.1%
11/181 • From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER