Details
| Stereochemistry | ABSOLUTE |
| Molecular Formula | C21H21F3IN3O2 |
| Molecular Weight | 531.31 |
| Optical Activity | UNSPECIFIED |
| Defined Stereocenters | 1 / 1 |
| E/Z Centers | 0 |
| Charge | 0 |
SHOW SMILES / InChI
SMILES
[H][C@]1(CCCCN1)C2(O)CN(C2)C(=O)C3=C(NC4=CC=C(I)C=C4F)C(F)=C(F)C=C3
InChI
InChIKey=BSMCAPRUBJMWDF-KRWDZBQOSA-N
InChI=1S/C21H21F3IN3O2/c22-14-6-5-13(19(18(14)24)27-16-7-4-12(25)9-15(16)23)20(29)28-10-21(30,11-28)17-3-1-2-8-26-17/h4-7,9,17,26-27,30H,1-3,8,10-11H2/t17-/m0/s1
DescriptionCurator's Comment: Description was created based on several sources, including
https://www.drugbank.ca/drugs/DB05239
http://www.exelixis.com/pipeline/GDC_0973_xl518
Curator's Comment: Description was created based on several sources, including
https://www.drugbank.ca/drugs/DB05239
http://www.exelixis.com/pipeline/GDC_0973_xl518
Cobimetinib is an orally active, potent and highly selective small molecule inhibiting mitogen-activated protein kinase kinase 1 (MAP2K1 or MEK1), and central components of the RAS/RAF/MEK/ERK signal transduction pathway. It has been approved in Switzerland and the US, in combination with vemurafenib for the treatment of patients with unresectable or metastatic BRAF V600 mutation-positive melanoma. Preclinical studies have demonstrated that Cobimetinib is effective in inhibiting the growth of tumor cells bearing a BRAF mutation, which has been found to be associated with many tumor types. A threonine-tyrosine kinase and a key component of the RAS/RAF/MEK/ERK signalling pathway that is frequently activated in human tumors, MEK1 is required for the transmission of growth-promoting signals from numerous receptor tyrosine kinases. Cobimetinib is used in combination with vemurafenib because the clinical benefit of a BRAF inhibitor is limited by intrinsic and acquired resistance. Reactivation of the MAPK pathway is a major contributor to treatment failure in BRAF-mutant melanomas, approximately ~80% of melanoma tumors becomes BRAF-inhibitor resistant due to reactivation of MAPK signalling. BRAF-inhibitor resistant tumor cells are sensitive to MEK inhibition, therefore cobimetinib and vemurafenib will result in dual inhibition of BRAF and its downstream target, MEK. Cobimetinib specifically binds to and inhibits the catalytic activity of MEK1, resulting in inhibition of extracellular signal-related kinase 2 (ERK2) phosphorylation and activation and decreased tumor cell proliferation. Cobimetinib and vemurafenib target two different kinases in the RAS/RAF/MEK/ERK pathway. Cobimetinib is used for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. Cobimetinib is used in combination with vemurafenib, a BRAF inhibitor. Cobimetinib is marketed under the trade name Cotellic.
Originator
Approval Year
Targets
| Primary Target | Pharmacology | Condition | Potency |
|---|---|---|---|
| 4.2 nM [IC50] |
Conditions
| Condition | Modality | Targets | Highest Phase | Product |
|---|---|---|---|---|
| Primary | COTELLIC Approved UseCOTELLIC is a kinase inhibitor indicated for the treatment of patients with
unresectable or metastatic melanoma with a BRAF V600E or V600K
mutation, in combination with vemurafenib. Launch Date2015 |
Cmax
| Value | Dose | Co-administered | Analyte | Population |
|---|---|---|---|---|
273 ng/mL |
60 mg 1 times / day steady-state, oral dose: 60 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
COBIMETINIB plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
AUC
| Value | Dose | Co-administered | Analyte | Population |
|---|---|---|---|---|
4340 ng × h/mL |
60 mg 1 times / day steady-state, oral dose: 60 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
COBIMETINIB plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
|
268 ng*h/mL Clinical Trial https://clinicaltrials.gov/ct2/show/NCT02300025 |
10 mg single, oral dose: 10 mg route of administration: oral experiment type: single co-administered: |
COBIMETINIB plasma | Homo sapiens population: unhealthy age: Adults sex: food status: Fasted |
|
498 ng*h/mL Clinical Trial https://clinicaltrials.gov/ct2/show/NCT02300025 |
10 mg single, oral dose: 10 mg route of administration: oral experiment type: single co-administered: |
COBIMETINIB plasma | Homo sapiens population: unhealthy age: Adults sex: food status: Fasted |
|
539 ng*h/mL Clinical Trial https://clinicaltrials.gov/ct2/show/NCT02300025 |
10 mg single, oral dose: 10 mg route of administration: oral experiment type: single co-administered: |
COBIMETINIB plasma | Homo sapiens population: unhealthy age: Adults sex: food status: Fasted |
T1/2
| Value | Dose | Co-administered | Analyte | Population |
|---|---|---|---|---|
44 h |
60 mg 1 times / day steady-state, oral dose: 60 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
COBIMETINIB plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
|
143 h Clinical Trial https://clinicaltrials.gov/ct2/show/NCT02300025 |
10 mg single, oral dose: 10 mg route of administration: oral experiment type: single co-administered: |
COBIMETINIB plasma | Homo sapiens population: unhealthy age: Adults sex: food status: Fasted |
|
95.2 h Clinical Trial https://clinicaltrials.gov/ct2/show/NCT02300025 |
10 mg single, oral dose: 10 mg route of administration: oral experiment type: single co-administered: |
COBIMETINIB plasma | Homo sapiens population: unhealthy age: Adults sex: food status: Fasted |
|
104 h Clinical Trial https://clinicaltrials.gov/ct2/show/NCT02300025 |
10 mg single, oral dose: 10 mg route of administration: oral experiment type: single co-administered: |
COBIMETINIB plasma | Homo sapiens population: unhealthy age: Adults sex: food status: Fasted |
Funbound
| Value | Dose | Co-administered | Analyte | Population |
|---|---|---|---|---|
5% |
60 mg 1 times / day steady-state, oral dose: 60 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
COBIMETINIB plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
Doses
| Dose | Population | Adverse events |
|---|---|---|
60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 185 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 185 Sources: |
Other AEs: Lymphopenia, Lymphopenia... Other AEs: Lymphopenia (grade 1-2, 63%) Sources: Lymphopenia (grade 3-4, 10%) |
60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 213 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 213 Sources: |
Other AEs: Creatine phosphokinase increased, Creatine phosphokinase increased... Other AEs: Creatine phosphokinase increased (grade 1-2, 65%) Sources: Creatine phosphokinase increased (grade 3-4, 14%) |
60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
Disc. AE: Aspartate aminotransferase increased, Gamma-glutamyltransferase increased... Other AEs: Rash, Diarrhea... AEs leading to discontinuation/dose reduction: Aspartate aminotransferase increased (2.4%) Other AEs:Gamma-glutamyltransferase increased (1.6%) Alanine aminotransferase increased (1.6%) Rash (1.6%) Pyrexia (1.2%) Retinal detachment (2%) Rash (11%) Sources: Diarrhea (9%) Chorioretinopathy (7%) Pyrexia (6%) Vomiting (6%) Nausea (5%) Creatine phosphokinase increased (4.9%) Diarrhea (grade 1-2, 54%) Diarrhea (grade 3-4, 6%) Nausea (grade 1-2, 40%) Nausea (grade 3-4, 1%) Vomiting (grade 1-2, 23%) Vomiting (grade 3-4, 1%) Stomatitis (grade 1-2, 13%) Aphthous stomatitis (grade 1-2, 13%) Mouth ulceration (grade 1-2, 13%) Mucosal inflammation (grade 1-2, 13%) Stomatitis (grade 3-4, 1%) Aphthous stomatitis (grade 3-4, 1%) Mouth ulceration (grade 3-4, 1%) Mucosal inflammation (grade 3-4, 1%) Solar dermatitis (grade 1-2, 42%) Sunburn (grade 1-2, 42%) Photosensitivity reaction (grade 1-2, 42%) Solar dermatitis (grade 3-4, 4%) Sunburn (grade 3-4, 4%) Photosensitivity reaction (grade 3-4, 4%) Acneiform dermatitis (grade 1-2, 14%) Acneiform dermatitis (grade 3-4, 2%) Pyrexia (grade 1-2, 26%) Pyrexia (grade 3-4, 2%) Chills (grade 1-2, 10%) Hypertension (grade 1-2, 11%) Hypertension (grade 3-4, 4%) Hemorrhage (grade 1-2, 12%) Rectal hemorrhage (grade 1-2, 12%) Melena (grade 1-2, 12%) Hemorrhoidal hemorrhage (grade 1-2, 12%) Gastrointestinal hemorrhage (grade 1-2, 12%) Hematemesis (grade 1-2, 12%) Hematochezia (grade 1-2, 12%) Gingival bleeding (grade 1-2, 12%) Metrorrhagia (grade 1-2, 12%) Uterine hemorrhage (grade 1-2, 12%) Hemorrhagic ovarian cyst (grade 1-2, 12%) Menometrorrhagia (grade 1-2, 12%) Menorrhagia (grade 1-2, 12%) Vaginal hemorrhage (grade 1-2, 12%) Hemoptysis (grade 1-2, 12%) Cerebral hemorrhage (grade 1-2, 12%) Subarachnoid hemorrhage (grade 1-2, 12%) Subgaleal hematoma (grade 1-2, 12%) Hematuria (grade 1-2, 12%) Epistaxis (grade 1-2, 12%) Contusion (grade 1-2, 12%) Traumatic hematoma (grade 1-2, 12%) Ecchymosis (grade 1-2, 12%) Purpura (grade 1-2, 12%) Nail bed bleeding (grade 1-2, 12%) Ocular hemorrhage (grade 1-2, 12%) Eye hemorrhage (grade 1-2, 12%) Conjunctival hemorrhage (grade 1-2, 12%) Retinal hemorrhage (grade 1-2, 12%) Hemorrhage (grade 3-4, 1%) Rectal hemorrhage (grade 3-4, 1%) Melena (grade 3-4, 1%) Hemorrhoidal hemorrhage (grade 3-4, 1%) Gastrointestinal hemorrhage (grade 3-4, 1%) Hematemesis (grade 3-4, 1%) Hematochezia (grade 3-4, 1%) Gingival bleeding (grade 3-4, 1%) Metrorrhagia (grade 3-4, 1%) Uterine hemorrhage (grade 3-4, 1%) Hemorrhagic ovarian cyst (grade 3-4, 1%) Menometrorrhagia (grade 3-4, 1%) Menorrhagia (grade 3-4, 1%) Vaginal hemorrhage (grade 3-4, 1%) Hemoptysis (grade 3-4, 1%) Cerebral hemorrhage (grade 3-4, 1%) Subarachnoid hemorrhage (grade 3-4, 1%) Subgaleal hematoma (grade 3-4, 1%) Hematuria (grade 3-4, 1%) Epistaxis (grade 3-4, 1%) Contusion (grade 3-4, 1%) Traumatic hematoma (grade 3-4, 1%) Ecchymosis (grade 3-4, 1%) Purpura (grade 3-4, 1%) Nail bed bleeding (grade 3-4, 1%) Ocular hemorrhage (grade 3-4, 1%) Eye hemorrhage (grade 3-4, 1%) Conjunctival hemorrhage (grade 3-4, 1%) Retinal hemorrhage (grade 3-4, 1%) Vision blurred (grade 1-2, 14%) Visual acuity reduced (grade 1-2, 14%) Visual impairment (grade 1-2, 14%) Vision blurred (grade 3-4, <1%) Visual acuity reduced (grade 3-4, <1%) Visual impairment (grade 3-4, <1%) Chorioretinopathy (grade 1-2, 13%) Chorioretinopathy (grade 3-4, <1%) Retinal detachment (grade 1-2, 10%) Detachment of retinal pigment epithelium (grade 1-2, 10%) Detachment of macular retinal pigment epithelium (grade 1-2, 10%) Retinal detachment (grade 3-4, 2%) Detachment of retinal pigment epithelium (grade 3-4, 2%) Detachment of macular retinal pigment epithelium (grade 3-4, 2%) Alopecia (15%) Hyperkeratosis (11%) Erythema (10%) Creatinine increased (grade 1-2, 96.3%) Creatinine increased (grade 3-4, 3.3%) AST increased (grade 1-2, 65%) AST increased (grade 3-4, 8%) ALT increased (grade 1-2, 57%) ALT increased (grade 3-4, 11%) Alkaline phosphatase increased (grade 1-2, 64%) Alkaline phosphatase increased (grade 3-4, 7%) Hypophosphatemia (grade 1-2, 56%) Hypophosphatemia (grade 3-4, 12%) GGT increased (grade 1-2, 44%) GGT increased (grade 3-4, 21%) Hyponatremia (grade 1-2, 32%) Hyponatremia (grade 3-4, 6%) Hypoalbuminemia (grade 1-2, 41.2%) Hypoalbuminemia (grade 3-4, 0.8%) Hypokalemia (grade 1-2, 20.5%) Hypokalemia (grade 3-4, 4.5%) Hyperkalemia (grade 1-2, 23.1%) Hyperkalemia (grade 3-4, 2.9%) Hypocalcemia (grade 1-2, 23.6%) Hypocalcemia (grade 3-4, 0.4%) Anemia (grade 1-2, 66.5%) Anemia (grade 3-4, 2.5%) Thrombocytopenia (grade 1-2, 18%) |
125 mg 1 times / day steady, oral Highest studied dose Dose: 125 mg, 1 times / day Route: oral Route: steady Dose: 125 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Sources: |
DLT: Rash, Central serous retinopathy... Dose limiting toxicities: Rash (grade 3) Sources: Central serous retinopathy (grade 3, 2 patients) |
80 mg 1 times / day steady, oral Highest studied dose Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
DLT: Diarrhea, Rash... Dose limiting toxicities: Diarrhea (grade 3, 1 patient) Sources: Rash (grade 3, 1 patient) |
100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
Other AEs: Diarrhea, Diarrhea... Other AEs: Diarrhea (all grades, 79%) Sources: Diarrhea (grade 3-5, 14%) Rash (all grades, 66%) Dermatitis acneiform (all grades, 66%) Rash pruritic (all grades, 66%) Generalized rash (all grades, 66%) Dermatitis (all grades, 66%) Exfoliative rash (all grades, 66%) Rash erythematous (all grades, 66%) Rash maculo-papular (all grades, 66%) Rash (grade 3-5, 10%) Dermatitis acneiform (grade 3-5, 10%) Rash pruritic (grade 3-5, 10%) Generalized rash (grade 3-5, 10%) Dermatitis (grade 3-5, 10%) Exfoliative rash (grade 3-5, 10%) Rash erythematous (grade 3-5, 10%) Rash maculo-papular (grade 3-5, 10%) Fatigue (all grades, 66%) Fatigue (grade 3-5, 7%) Peripheral edema (all grades, 34%) Periorbital edema (all grades, 34%) Edema (all grades, 34%) Edema face (all grades, 34%) Nausea (all grades, 41%) Vomiting (all grades, 48%) Abnormal sensation in eye (all grades, 24%) Retinal edema (all grades, 24%) Photopsia (all grades, 24%) Blurred vision (all grades, 24%) Central serous retinopathy (all grades, 24%) Vitreous floaters (all grades, 24%) Eye disorder NOS (all grades, 24%) Abnormal sensation in eye (grade 3-5, 3%) Retinal edema (grade 3-5, 3%) Photopsia (grade 3-5, 3%) Blurred vision (grade 3-5, 3%) Central serous retinopathy (grade 3-5, 3%) Vitreous floaters (grade 3-5, 3%) Eye disorder NOS (grade 3-5, 3%) Abdominal pain upper (all grades, 35%) Abdominal pain lower (all grades, 35%) Abdominal discomfort (all grades, 35%) Abdominal tenderness (all grades, 35%) Abdominal pain upper (grade 3-5, 3%) Abdominal pain lower (grade 3-5, 3%) Abdominal discomfort (grade 3-5, 3%) Abdominal tenderness (grade 3-5, 3%) Stomatitis (all grades, 10%) Dry skin (all grades, 10%) |
60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
DLT: Rash, Dermatitis acneiform... Other AEs: Diarrhea, Rash... Dose limiting toxicities: Rash (grade 3-5, 4%) Other AEs:Dermatitis acneiform (grade 3-5, 4%) Rash pruritic (grade 3-5, 4%) Generalized rash (grade 3-5, 4%) Dermatitis (grade 3-5, 4%) Exfoliative rash (grade 3-5, 4%) Rash erythematous (grade 3-5, 4%) Rash maculo-papular (grade 3-5, 4%) Diarrhea (all grades, 56%) Sources: Rash (all grades, 67%) Dermatitis acneiform (all grades, 67%) Rash pruritic (all grades, 67%) Generalized rash (all grades, 67%) Dermatitis (all grades, 67%) Exfoliative rash (all grades, 67%) Rash erythematous (all grades, 67%) Rash maculo-papular (all grades, 67%) Fatigue (all grades, 33%) Fatigue (grade 3-5, 11%) Peripheral edema (all grades, 33%) Periorbital edema (all grades, 33%) Edema (all grades, 33%) Edema face (all grades, 33%) Nausea (all grades, 22%) Vomiting (all grades, 11%) Abnormal sensation in eye (all grades, 15%) Retinal edema (all grades, 15%) Photopsia (all grades, 15%) Blurred vision (all grades, 15%) Central serous retinopathy (all grades, 15%) Vitreous floaters (all grades, 15%) Eye disorder NOS (all grades, 15%) Stomatitis (all grades, 11%) Dry skin (all grades, 7%) |
40 mg 1 times / day steady, oral Dose: 40 mg, 1 times / day Route: oral Route: steady Dose: 40 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
DLT: Encephalopathy... Dose limiting toxicities: Encephalopathy (grade 4, 1 patient) Sources: |
AEs
| AE | Significance | Dose | Population |
|---|---|---|---|
| Lymphopenia | grade 1-2, 63% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 185 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 185 Sources: |
| Lymphopenia | grade 3-4, 10% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 185 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 185 Sources: |
| Creatine phosphokinase increased | grade 1-2, 65% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 213 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 213 Sources: |
| Creatine phosphokinase increased | grade 3-4, 14% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 213 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 213 Sources: |
| Pyrexia | 1.2% Disc. AE |
60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Alanine aminotransferase increased | 1.6% Disc. AE |
60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Gamma-glutamyltransferase increased | 1.6% Disc. AE |
60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Rash | 1.6% Disc. AE |
60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Erythema | 10% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hyperkeratosis | 11% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Rash | 11% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Alopecia | 15% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Retinal detachment | 2% Disc. AE |
60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Aspartate aminotransferase increased | 2.4% Disc. AE |
60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Creatine phosphokinase increased | 4.9% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Nausea | 5% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Pyrexia | 6% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Vomiting | 6% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Chorioretinopathy | 7% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Diarrhea | 9% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Chills | grade 1-2, 10% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Detachment of macular retinal pigment epithelium | grade 1-2, 10% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Detachment of retinal pigment epithelium | grade 1-2, 10% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Retinal detachment | grade 1-2, 10% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hypertension | grade 1-2, 11% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Cerebral hemorrhage | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Conjunctival hemorrhage | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Contusion | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Ecchymosis | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Epistaxis | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Eye hemorrhage | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Gastrointestinal hemorrhage | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Gingival bleeding | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hematemesis | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hematochezia | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hematuria | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hemoptysis | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hemorrhage | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hemorrhagic ovarian cyst | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hemorrhoidal hemorrhage | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Melena | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Menometrorrhagia | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Menorrhagia | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Metrorrhagia | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Nail bed bleeding | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Ocular hemorrhage | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Purpura | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Rectal hemorrhage | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Retinal hemorrhage | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Subarachnoid hemorrhage | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Subgaleal hematoma | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Traumatic hematoma | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Uterine hemorrhage | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Vaginal hemorrhage | grade 1-2, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Aphthous stomatitis | grade 1-2, 13% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Chorioretinopathy | grade 1-2, 13% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Mouth ulceration | grade 1-2, 13% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Mucosal inflammation | grade 1-2, 13% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Stomatitis | grade 1-2, 13% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Acneiform dermatitis | grade 1-2, 14% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Vision blurred | grade 1-2, 14% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Visual acuity reduced | grade 1-2, 14% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Visual impairment | grade 1-2, 14% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Thrombocytopenia | grade 1-2, 18% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hypokalemia | grade 1-2, 20.5% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Vomiting | grade 1-2, 23% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hyperkalemia | grade 1-2, 23.1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hypocalcemia | grade 1-2, 23.6% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Pyrexia | grade 1-2, 26% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hyponatremia | grade 1-2, 32% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Nausea | grade 1-2, 40% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hypoalbuminemia | grade 1-2, 41.2% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Photosensitivity reaction | grade 1-2, 42% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Solar dermatitis | grade 1-2, 42% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Sunburn | grade 1-2, 42% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| GGT increased | grade 1-2, 44% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Diarrhea | grade 1-2, 54% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hypophosphatemia | grade 1-2, 56% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| ALT increased | grade 1-2, 57% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Alkaline phosphatase increased | grade 1-2, 64% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| AST increased | grade 1-2, 65% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Anemia | grade 1-2, 66.5% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Creatinine increased | grade 1-2, 96.3% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hypocalcemia | grade 3-4, 0.4% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hypoalbuminemia | grade 3-4, 0.8% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Aphthous stomatitis | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Cerebral hemorrhage | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Conjunctival hemorrhage | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Contusion | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Ecchymosis | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Epistaxis | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Eye hemorrhage | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Gastrointestinal hemorrhage | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Gingival bleeding | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hematemesis | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hematochezia | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hematuria | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hemoptysis | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hemorrhage | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hemorrhagic ovarian cyst | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hemorrhoidal hemorrhage | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Melena | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Menometrorrhagia | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Menorrhagia | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Metrorrhagia | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Mouth ulceration | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Mucosal inflammation | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Nail bed bleeding | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Nausea | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Ocular hemorrhage | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Purpura | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Rectal hemorrhage | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Retinal hemorrhage | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Stomatitis | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Subarachnoid hemorrhage | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Subgaleal hematoma | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Traumatic hematoma | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Uterine hemorrhage | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Vaginal hemorrhage | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Vomiting | grade 3-4, 1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| ALT increased | grade 3-4, 11% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hypophosphatemia | grade 3-4, 12% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Acneiform dermatitis | grade 3-4, 2% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Detachment of macular retinal pigment epithelium | grade 3-4, 2% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Detachment of retinal pigment epithelium | grade 3-4, 2% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Pyrexia | grade 3-4, 2% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Retinal detachment | grade 3-4, 2% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Anemia | grade 3-4, 2.5% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hyperkalemia | grade 3-4, 2.9% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| GGT increased | grade 3-4, 21% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Creatinine increased | grade 3-4, 3.3% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hypertension | grade 3-4, 4% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Photosensitivity reaction | grade 3-4, 4% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Solar dermatitis | grade 3-4, 4% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Sunburn | grade 3-4, 4% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hypokalemia | grade 3-4, 4.5% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Diarrhea | grade 3-4, 6% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Hyponatremia | grade 3-4, 6% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Alkaline phosphatase increased | grade 3-4, 7% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| AST increased | grade 3-4, 8% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Chorioretinopathy | grade 3-4, <1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Vision blurred | grade 3-4, <1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Visual acuity reduced | grade 3-4, <1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Visual impairment | grade 3-4, <1% | 60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Co-administed with:: vemurafenib(960 mg twice daily on Days 1 -28) Sources: |
unhealthy, 55 years (range: 23 - 88 years) n = 247 Health Status: unhealthy Condition: BRAF V600 mutation-positive, unresectable or metastatic melanoma Age Group: 55 years (range: 23 - 88 years) Sex: M+F Population Size: 247 Sources: |
| Central serous retinopathy | grade 3, 2 patients DLT, Disc. AE |
125 mg 1 times / day steady, oral Highest studied dose Dose: 125 mg, 1 times / day Route: oral Route: steady Dose: 125 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Sources: |
| Rash | grade 3 DLT |
125 mg 1 times / day steady, oral Highest studied dose Dose: 125 mg, 1 times / day Route: oral Route: steady Dose: 125 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Sources: |
| Diarrhea | grade 3, 1 patient DLT |
80 mg 1 times / day steady, oral Highest studied dose Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Rash | grade 3, 1 patient DLT |
80 mg 1 times / day steady, oral Highest studied dose Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Dry skin | all grades, 10% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Stomatitis | all grades, 10% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Abnormal sensation in eye | all grades, 24% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Blurred vision | all grades, 24% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Central serous retinopathy | all grades, 24% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Eye disorder NOS | all grades, 24% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Photopsia | all grades, 24% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Retinal edema | all grades, 24% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Vitreous floaters | all grades, 24% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Edema face | all grades, 34% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Edema | all grades, 34% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Periorbital edema | all grades, 34% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Peripheral edema | all grades, 34% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Abdominal discomfort | all grades, 35% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Abdominal pain lower | all grades, 35% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Abdominal pain upper | all grades, 35% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Abdominal tenderness | all grades, 35% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Nausea | all grades, 41% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Vomiting | all grades, 48% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Dermatitis acneiform | all grades, 66% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Dermatitis | all grades, 66% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Exfoliative rash | all grades, 66% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Fatigue | all grades, 66% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Generalized rash | all grades, 66% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Rash erythematous | all grades, 66% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Rash maculo-papular | all grades, 66% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Rash pruritic | all grades, 66% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Rash | all grades, 66% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Diarrhea | all grades, 79% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Dermatitis acneiform | grade 3-5, 10% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Dermatitis | grade 3-5, 10% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Exfoliative rash | grade 3-5, 10% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Generalized rash | grade 3-5, 10% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Rash erythematous | grade 3-5, 10% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Rash maculo-papular | grade 3-5, 10% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Rash pruritic | grade 3-5, 10% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Rash | grade 3-5, 10% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Diarrhea | grade 3-5, 14% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Abdominal discomfort | grade 3-5, 3% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Abdominal pain lower | grade 3-5, 3% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Abdominal pain upper | grade 3-5, 3% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Abdominal tenderness | grade 3-5, 3% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Abnormal sensation in eye | grade 3-5, 3% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Blurred vision | grade 3-5, 3% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Central serous retinopathy | grade 3-5, 3% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Eye disorder NOS | grade 3-5, 3% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Photopsia | grade 3-5, 3% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Retinal edema | grade 3-5, 3% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Vitreous floaters | grade 3-5, 3% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Fatigue | grade 3-5, 7% | 100 mg 1 times / day steady, oral MTD Dose: 100 mg, 1 times / day Route: oral Route: steady Dose: 100 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 29 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 29 Sources: |
| Stomatitis | all grades, 11% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Vomiting | all grades, 11% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Abnormal sensation in eye | all grades, 15% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Blurred vision | all grades, 15% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Central serous retinopathy | all grades, 15% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Eye disorder NOS | all grades, 15% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Photopsia | all grades, 15% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Retinal edema | all grades, 15% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Vitreous floaters | all grades, 15% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Nausea | all grades, 22% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Edema face | all grades, 33% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Edema | all grades, 33% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Fatigue | all grades, 33% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Periorbital edema | all grades, 33% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Peripheral edema | all grades, 33% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Diarrhea | all grades, 56% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Dermatitis acneiform | all grades, 67% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Dermatitis | all grades, 67% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Exfoliative rash | all grades, 67% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Generalized rash | all grades, 67% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Rash erythematous | all grades, 67% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Rash maculo-papular | all grades, 67% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Rash pruritic | all grades, 67% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Rash | all grades, 67% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Dry skin | all grades, 7% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Fatigue | grade 3-5, 11% | 60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Dermatitis acneiform | grade 3-5, 4% DLT, Disc. AE |
60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Dermatitis | grade 3-5, 4% DLT, Disc. AE |
60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Exfoliative rash | grade 3-5, 4% DLT, Disc. AE |
60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Generalized rash | grade 3-5, 4% DLT, Disc. AE |
60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Rash erythematous | grade 3-5, 4% DLT, Disc. AE |
60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Rash maculo-papular | grade 3-5, 4% DLT, Disc. AE |
60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Rash pruritic | grade 3-5, 4% DLT, Disc. AE |
60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Rash | grade 3-5, 4% DLT, Disc. AE |
60 mg 1 times / day steady, oral MTD Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
| Encephalopathy | grade 4, 1 patient DLT, Disc. AE |
40 mg 1 times / day steady, oral Dose: 40 mg, 1 times / day Route: oral Route: steady Dose: 40 mg, 1 times / day Sources: |
unhealthy, 60 years (range: 30−82 years) n = 27 Health Status: unhealthy Condition: metastatic or unresectable solid tumors Age Group: 60 years (range: 30−82 years) Sex: M+F Population Size: 27 Sources: |
Overview
| CYP3A4 | CYP2C9 | CYP2D6 | hERG |
|---|---|---|---|
OverviewOther
| Other Inhibitor | Other Substrate | Other Inducer |
|---|---|---|
Drug as perpetrator
| Target | Modality | Activity | Metabolite | Clinical evidence |
|---|---|---|---|---|
| no [IC50 118 uM] | ||||
| no [IC50 40 uM] | ||||
| no [IC50 85 uM] | ||||
| no [IC50 >50 uM] | ||||
| no [IC50 >50 uM] | ||||
| no [IC50 >50 uM] | ||||
| no [IC50 >50 uM] | ||||
| no [IC50 >50 uM] | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| yes [IC50 1.8 uM] | no (co-administration study) Comment: Coadministration of cobimetinib 60 mg QD for 15 days with a single dose of dextromethorphan 2 mg did not change dextromethorphan exposure Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206192Orig1s000ClinPharmR.pdf#page=38 Page: 38.0 |
|||
| yes [IC50 17 uM] | no (co-administration study) Comment: Coadministration of cobimetinib 60 mg QD for 15 days with a single dose of midazolam 2 mg did not change midazolam exposure Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206192Orig1s000ClinPharmR.pdf#page=38 Page: 38.0 |
|||
| yes |
Drug as victim
| Target | Modality | Activity | Metabolite | Clinical evidence |
|---|---|---|---|---|
| major | yes (co-administration study) Comment: Coadministration of itraconazole 200 mg QD for 14 days with a single dose of 10 mg cobimetinib increased cobimetinib AUC by 6.7-fold (90% CI: 5.6, 8.0) and Cmax by 3.2-fold (90% CI: 2.7, 3.7) as compared with cobimetinib alone Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206192Orig1s000ClinPharmR.pdf#page=37 Page: 37.0 |
|||
| minor | ||||
| minor | ||||
| minor | ||||
| minor | ||||
| minor | ||||
| minor | ||||
| minor | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| yes | ||||
| yes |
Tox targets
| Target | Modality | Activity | Metabolite | Clinical evidence |
|---|---|---|---|---|
PubMed
| Title | Date | PubMed |
|---|---|---|
| Mutations of the BRAF gene in human cancer. | 2002 Jun 27 |
|
| Mechanism of activation of the RAF-ERK signaling pathway by oncogenic mutations of B-RAF. | 2004 Mar 19 |
|
| Intermittent administration of MEK inhibitor GDC-0973 plus PI3K inhibitor GDC-0941 triggers robust apoptosis and tumor growth inhibition. | 2012 Jan 1 |
|
| The role of BRAF V600 mutation in melanoma. | 2012 Jul 9 |
|
| MEK and the inhibitors: from bench to bedside. | 2013 Apr 12 |
|
| Population pharmacokinetics and dosing implications for cobimetinib in patients with solid tumors. | 2015 Nov |
|
| Cobimetinib: First Global Approval. | 2015 Oct |
|
| Targeted inhibition of MEK1 by cobimetinib leads to differentiation and apoptosis in neuroblastoma cells. | 2015 Sep 18 |
|
| MEK inhibitors and their potential in the treatment of advanced melanoma: the advantages of combination therapy. | 2016 |
|
| Absorption, Metabolism, Excretion, and the Contribution of Intestinal Metabolism to the Oral Disposition of [14C]Cobimetinib, a MEK Inhibitor, in Humans. | 2016 Jan |
Patents
Sample Use Guides
The recommended dose is 60 mg orally once daily for the first 21 days of each 28-day cycle until disease progression or unacceptable toxicity.
Route of Administration:
Oral
| Name | Type | Language | ||
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Common Name | English | ||
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Code | English | ||
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Common Name | English | ||
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Code | English | ||
|
Code | English | ||
|
Systematic Name | English |
| Classification Tree | Code System | Code | ||
|---|---|---|---|---|
|
WHO-ATC |
L01XE38
Created by
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|
FDA ORPHAN DRUG |
752820
Created by
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|
NCI_THESAURUS |
C129825
Created by
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NDF-RT |
N0000175605
Created by
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FDA ORPHAN DRUG |
419513
Created by
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NCI_THESAURUS |
C69145
Created by
admin on Fri Dec 15 21:20:55 GMT 2023 , Edited by admin on Fri Dec 15 21:20:55 GMT 2023
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| Code System | Code | Type | Description | ||
|---|---|---|---|---|---|
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CHEMBL2146883
Created by
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PRIMARY | |||
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N0000175082
Created by
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PRIMARY | Kinase Inhibitors [MoA] | ||
|
90853
Created by
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PRIMARY | |||
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C68923
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ER29L26N1X
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PRIMARY | |||
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1722365
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PRIMARY | RxNorm | ||
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16222096
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PRIMARY | |||
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SUB122319
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9645
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ER29L26N1X
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PRIMARY | |||
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ZZ-137
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PRIMARY | |||
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m11872
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PRIMARY | |||
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90851
Created by
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PRIMARY | |||
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Cobimetinib
Created by
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PRIMARY | |||
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5046
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PRIMARY | |||
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CHEMBL3330650
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PRIMARY | |||
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100000144958
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PRIMARY | |||
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DB05239
Created by
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PRIMARY | |||
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934660-93-2
Created by
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PRIMARY | |||
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Cobimetinib
Created by
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PRIMARY | |||
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DTXSID60239435
Created by
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PRIMARY |
ACTIVE MOIETY
METABOLITE (PARENT)
METABOLITE (PARENT)
METABOLITE (PARENT)
SALT/SOLVATE (PARENT)
