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Details

Stereochemistry ACHIRAL
Molecular Formula C26H23FIN5O4
Molecular Weight 615.3958
Optical Activity NONE
Defined Stereocenters 0 / 0
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of TRAMETINIB

SMILES

Cc1c2c(c(Nc3ccc(cc3F)I)n(C)c1=O)c(=O)n(C4CC4)c(=O)n2-c5cccc(c5)N=C(C)O

InChI

InChIKey=LIRYPHYGHXZJBZ-UHFFFAOYSA-N
InChI=1S/C26H23FIN5O4/c1-13-22-21(23(31(3)24(13)35)30-20-10-7-15(28)11-19(20)27)25(36)33(17-8-9-17)26(37)32(22)18-6-4-5-16(12-18)29-14(2)34/h4-7,10-12,17,30H,8-9H2,1-3H3,(H,29,34)

HIDE SMILES / InChI

Description
Curator's Comment:: description was created based on several sources, including http://www.ncbi.nlm.nih.gov/pubmed/?term=24875464; http://www.ncbi.nlm.nih.gov/pubmed/23846731

Trametinib is a reversible and specific inhibitor of mitogen-activated protein kinase kinases MEK1 and MEK2 which are involved in a RAS/RAF/MEK/ERK signaling pathway and control cell growth, survival, and differentiation. By inhibiting MEK1 and MEK2 trametinib blocks dual phosphorylation of ERK1/2 and stops cell cycling. In addition, trametinib blocks BRAF pathway in the cells with BRAF V600E mutations. Trametinib (as a single agent and in combination with dabrafenib) is approved for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations.

CNS Activity

Curator's Comment:: Trametinib crosses blood-brain barrier and has anticancer activity in the CNS

Originator

Curator's Comment:: Originally developed by Japan Tobacco, GlaxoSmithKline has licensed exclusive worldwide rights to the compound and conducted development in a number of different cancer types.

Approval Year

Targets

Targets

Primary TargetPharmacologyConditionPotency
Target ID: Q02750
Gene ID: 5604.0
Gene Symbol: MAP2K1
Target Organism: Homo sapiens (Human)
0.9 nM [IC50]
Target ID: P36507
Gene ID: 5605.0
Gene Symbol: MAP2K2
Target Organism: Homo sapiens (Human)
1.8 nM [IC50]
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
MEKINIST

Approved Use

Indicated, as a single agent or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations

Launch Date

1.36978563E12
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
9.5 ng/mL
2 mg single, oral
dose: 2 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
TRAMETINIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
8.03 ng/mL
2 mg single, oral
dose: 2 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
TRAMETINIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
498 ng × h/mL
2 mg single, oral
dose: 2 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
TRAMETINIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
525 ng × h/mL
2 mg single, oral
dose: 2 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
TRAMETINIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
127 h
2 mg single, oral
dose: 2 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
TRAMETINIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
264 h
2 mg single, oral
dose: 2 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
TRAMETINIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
5%
2 mg single, oral
dose: 2 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
TRAMETINIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
Doses

Doses

DosePopulationAdverse events​
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Disc. AE: Left ventricular dysfunction, Cardiac failure...
AEs leading to
discontinuation/dose reduction:
Left ventricular dysfunction (0.9%)
Cardiac failure (0.5%)
Myocardial infarction (0.5%)
Tachycardia (0.5%)
ALT increased (0.5%)
Bilirubin increased (0.5%)
GGT increased (0.5%)
CPK increased (0.5%)
Pneumonitis (0.9%)
Renal failure (0.9%)
Rash (0.9%)
Erythema nodosum (0.5%)
Chorioretinopathy (0.5%)
Retinal detachment (0.5%)
Hepatic failure (0.5%)
Hepatitis (0.5%)
Hepatobiliary disease (0.5%)
Duodenal perforation (0.5%)
Esophagitis (0.5%)
Vomiting (0.5%)
Diarrhea (0.5%)
Abdominal pain upper (0.5%)
Face edema (0.5%)
Edema peripheral (0.5%)
Fatigue (0.5%)
Pyrexia (0.5%)
Decreased appetite (0.5%)
Hyponatremia (0.5%)
Cell death (0.5%)
Hypersensitivity (0.5%)
Corneal graft rejection (0.5%)
Anemia (0.5%)
Sources: Page: 204114Orig1s000MedR.pdf - p.92
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Disc. AE: Rash, Diarrhea...
Other AEs: Hypertension, Rash...
AEs leading to
discontinuation/dose reduction:
Rash (4%)
Diarrhea (2%)
Peripheral edema (2%)
Transaminases increased (1%)
Cardiac disorder (1%)
Cellulitis (1%)
Nausea (1%)
Pyrexia (1%)
Rash (9%)
Acne (0.9%)
Dermatitis acneiform (0.9%)
Pruritus (0.9%)
Erythema (0.5%)
Rash maculo-papular (0.5%)
Rash papular (0.5%)
Skin ulcer (0.5%)
Toxic skin eruption (0.5%)
ALT increased (3%)
AST increased (0.9%)
CPK increased (0.9%)
Alkaline phosphatase increased (0.5%)
Electrocardiogram abnormal (0.5%)
Decreased hemoglobin (0.5%)
Stomatitis (0.9%)
Abdominal pain (0.5%)
Anal ulcer (0.5%)
Diarrhea (0.5%)
Lip ulceration (0.5%)
Oral pain (0.5%)
Rash pustular (0.9%)
Folliculitis (0.5%)
Klebsiella infection (0.5%)
Nail infection (0.5%)
Pulpitis dental (0.5%)
Fatigue (0.9%)
Mucosal inflammation (0.9%)
Pyrexia (0.5%)
Rhabdomyolysis (0.9%)
Neck pain (0.5%)
Exertional dyspnea (0.5%)
Interstitial lung disease (0.5%)
Nasal ulcer (0.5%)
Conduction disorder (0.5%)
Left ventricular dysfunction (0.5%)
Hypertension (0.9%)
Central serous retinopathy (0.5%)
Hypertriglyceridemia (0.5%)
Rash (grade 3, 7%)
Acne (grade 3, 0.5%)
Pruritus (grade 3, 0.9%)
Rash papular (grade 3, 0.5%)
ALT increased (grade 3, 0.9%)
CPK increased (grade 3, 0.5%)
Decreased hemoglobin (grade 3, 0.5%)
Stomatitis (grade 3, 0.5%)
Abdominal pain (grade 3, 0.5%)
Lip ulceration (grade 3, 0.5%)
Oral pain (grade 3, 0.5%)
Rash pustular (grade 3, 0.5%)
Folliculitis (grade 3, 0.5%)
Klebsiella infection (grade 3, 0.5%)
Fatigue (grade 3, 0.9%)
Mucosal inflammation (grade 3, 0.9%)
Rhabdomyolysis (grade 3, 0.9%)
Exertional dyspnea (grade 3, 0.5%)
Interstitial lung disease (grade 3, 0.5%)
Conduction disorder (grade 3, 0.5%)
Hypertension (grade 3, 0.9%)
Hypertriglyceridemia (grade 3, 0.5%)
Other AEs:
Hypertension (grade 3, 13%)
Rash (grade 3, 8%)
Fatigue (grade 3, 4%)
Anemia (grade 3, 2%)
Dehydration (grade 3, 1%)
ALT increased (grade 3, 2%)
Dyspnea (grade 3, 1%)
Hypoalbuminemia (grade 3, 1%)
Pruritus (grade 3, 2%)
Vomiting (grade 3, 1%)
CPK increased (grade 3, 1%)
Cellulitis (grade 3, 1%)
Infection (grade 3, 1%)
Rash (grade 4, 0.5%)
Dehydration (grade 4, 0.5%)
Dyspnea (grade 4, 0.5%)
Sources: Page: 204114Orig1s000MedR.pdf - p.99
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources: Page: 204114Orig1s000SumR.pdf - p.21
unhealthy, median age 55 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 55 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000SumR.pdf - p.21
Other AEs: Skin rash, Skin rash...
Other AEs:
Skin rash (grade 3, 7.1%)
Skin rash (grade 4, 0.5%)
Fatigue (grade 3, 4%)
Peripheral edema (grade 3, 1%)
Acneiform dermatitis (grade 3, 1%)
Nausea (grade 3, 1%)
Alopecia (grade 3, <1%)
Hypertension (grade 3, 12%)
Vomiting (grade 3, 1%)
Sources: Page: 204114Orig1s000SumR.pdf - p.21
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 55 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 55 years
Sex: M+F
Population Size: 211
Sources:
Other AEs: Detachment of retinal pigment epithelium, Retinal vein occlusion...
Other AEs:
Detachment of retinal pigment epithelium (0.5%)
Retinal vein occlusion (0.6%)
Interstitial lung disease (2.4%)
Skin rash (6%)
Sources:
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources: Page: 204114Orig1s000SumR.pdf - p.21
unhealthy, median age 55 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 55 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000SumR.pdf - p.21
Other AEs: Cardiomyopathy...
Other AEs:
Cardiomyopathy (7%)
Sources: Page: 204114Orig1s000SumR.pdf - p.21
10 mg 1 times / day multiple, oral
Highest studied dose
Dose: 10 mg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 4
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 4
Sources:
DLT: Central serous retinopathy, Diarrhoea...
Dose limiting toxicities:
Central serous retinopathy (grade 2)
Diarrhoea (grade 3)
Rash (grade 3)
Sources:
10 mg 1 times / day multiple, oral
Highest studied dose
Dose: 10 mg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 4
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 4
Sources:
Other AEs: Detachment of retinal pigment epithelium...
4 mg 1 times / day multiple, oral
Highest studied dose
Dose: 4 mg, 1 times / day
Route: oral
Route: multiple
Dose: 4 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 3
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 3
Sources:
DLT: Central serous retinopathy...
Dose limiting toxicities:
Central serous retinopathy (grade 2)
Sources:
4 mg 1 times / day multiple, oral
Highest studied dose
Dose: 4 mg, 1 times / day
Route: oral
Route: multiple
Dose: 4 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 3
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 3
Sources:
3 mg 1 times / day multiple, oral
MTD
unhealthy, median age 58.5 years
n = 12
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 12
Sources:
Disc. AE: Fatigue...
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Other AEs: Acneiform dermatitis, Diarrhoea...
Other AEs:
Acneiform dermatitis (grade 1, 49%)
Diarrhoea (grade 1, 34%)
Fatigue (grade 1, 19%)
Peripheral oedema (grade 1, 26%)
Nausea (grade 1, 20%)
Vomiting (grade 1, 7%)
Pruritus (grade 1, 14%)
Fissures of skin (grade 1, 16%)
Decreased appetite (grade 1, 9%)
Eye disorders NEC (grade 1, 9%)
Mucosal inflammation (grade 1, 4%)
Constipation (grade 1, 3%)
Left ventricular ejection fraction decreased (grade 1, 3%)
Periorbital oedema (grade 1, 7%)
Thrombocytopenia (grade 1, 1%)
Dry mouth (grade 1, 3%)
Acneiform dermatitis (grade 2, 31%)
Diarrhoea (grade 2, 10%)
Fatigue (grade 2, 10%)
Peripheral oedema (grade 2, 3%)
Nausea (grade 2, 6%)
Vomiting (grade 2, 4%)
Pruritus (grade 2, 6%)
Fissures of skin (grade 2, 6%)
Decreased appetite (grade 2, 1%)
Constipation (grade 2, 1%)
Left ventricular ejection fraction decreased (grade 2, 6%)
Acneiform dermatitis (grade 3, 4%)
Diarrhoea (grade 3, 1%)
Fatigue (grade 3, 1%)
Vomiting (grade 3, 1%)
Eye disorders NEC (grade 3, 1%)
Left ventricular ejection fraction decreased (grade 3, 1%)
Sources:
2 mg 1 times / day multiple, oral
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 3
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 3
Sources:
DLT: Rash...
Dose limiting toxicities:
Rash (grade 3)
Sources:
AEs

AEs

AESignificanceDosePopulation
ALT increased 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Abdominal pain upper 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Anemia 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Bilirubin increased 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
CPK increased 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Cardiac failure 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Cell death 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Chorioretinopathy 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Corneal graft rejection 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Decreased appetite 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Diarrhea 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Duodenal perforation 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Edema peripheral 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Erythema nodosum 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Esophagitis 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Face edema 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Fatigue 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
GGT increased 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Hepatic failure 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Hepatitis 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Hepatobiliary disease 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Hypersensitivity 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Hyponatremia 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Myocardial infarction 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Pyrexia 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Retinal detachment 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Tachycardia 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Vomiting 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Left ventricular dysfunction 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Pneumonitis 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Rash 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Renal failure 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.92
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.92
Abdominal pain 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Alkaline phosphatase increased 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Anal ulcer 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Central serous retinopathy 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Conduction disorder 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Decreased hemoglobin 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Diarrhea 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Electrocardiogram abnormal 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Erythema 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Exertional dyspnea 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Folliculitis 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Hypertriglyceridemia 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Interstitial lung disease 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Klebsiella infection 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Left ventricular dysfunction 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Lip ulceration 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Nail infection 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Nasal ulcer 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Neck pain 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Oral pain 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Pulpitis dental 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Pyrexia 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Rash maculo-papular 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Rash papular 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Skin ulcer 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Toxic skin eruption 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
AST increased 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Acne 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
CPK increased 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Dermatitis acneiform 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Fatigue 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Hypertension 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Mucosal inflammation 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Pruritus 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Rash pustular 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Rhabdomyolysis 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Stomatitis 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Cardiac disorder 1%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Cellulitis 1%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Nausea 1%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Pyrexia 1%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Transaminases increased 1%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Diarrhea 2%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Peripheral edema 2%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
ALT increased 3%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Rash 4%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Rash 9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Abdominal pain grade 3, 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Acne grade 3, 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
CPK increased grade 3, 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Conduction disorder grade 3, 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Decreased hemoglobin grade 3, 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Exertional dyspnea grade 3, 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Folliculitis grade 3, 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Hypertriglyceridemia grade 3, 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Interstitial lung disease grade 3, 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Klebsiella infection grade 3, 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Lip ulceration grade 3, 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Oral pain grade 3, 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Rash papular grade 3, 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Rash pustular grade 3, 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Stomatitis grade 3, 0.5%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
ALT increased grade 3, 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Fatigue grade 3, 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Hypertension grade 3, 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Mucosal inflammation grade 3, 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Pruritus grade 3, 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Rhabdomyolysis grade 3, 0.9%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
CPK increased grade 3, 1%
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Cellulitis grade 3, 1%
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Dehydration grade 3, 1%
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Dyspnea grade 3, 1%
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Hypoalbuminemia grade 3, 1%
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Infection grade 3, 1%
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Vomiting grade 3, 1%
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Hypertension grade 3, 13%
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
ALT increased grade 3, 2%
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Anemia grade 3, 2%
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Pruritus grade 3, 2%
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Fatigue grade 3, 4%
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Rash grade 3, 7%
Disc. AE
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Rash grade 3, 8%
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Dehydration grade 4, 0.5%
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Dyspnea grade 4, 0.5%
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Rash grade 4, 0.5%
2 mg 2 times / day multiple, oral
Dose: 2 mg, 2 times / day
Route: oral
Route: multiple
Dose: 2 mg, 2 times / day
Sources: Page: 204114Orig1s000MedR.pdf - p.99
unhealthy, median age 54.5 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 54.5 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000MedR.pdf - p.99
Acneiform dermatitis grade 3, 1%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources: Page: 204114Orig1s000SumR.pdf - p.21
unhealthy, median age 55 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 55 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000SumR.pdf - p.21
Nausea grade 3, 1%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources: Page: 204114Orig1s000SumR.pdf - p.21
unhealthy, median age 55 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 55 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000SumR.pdf - p.21
Peripheral edema grade 3, 1%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources: Page: 204114Orig1s000SumR.pdf - p.21
unhealthy, median age 55 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 55 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000SumR.pdf - p.21
Vomiting grade 3, 1%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources: Page: 204114Orig1s000SumR.pdf - p.21
unhealthy, median age 55 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 55 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000SumR.pdf - p.21
Hypertension grade 3, 12%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources: Page: 204114Orig1s000SumR.pdf - p.21
unhealthy, median age 55 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 55 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000SumR.pdf - p.21
Fatigue grade 3, 4%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources: Page: 204114Orig1s000SumR.pdf - p.21
unhealthy, median age 55 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 55 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000SumR.pdf - p.21
Skin rash grade 3, 7.1%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources: Page: 204114Orig1s000SumR.pdf - p.21
unhealthy, median age 55 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 55 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000SumR.pdf - p.21
Alopecia grade 3, <1%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources: Page: 204114Orig1s000SumR.pdf - p.21
unhealthy, median age 55 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 55 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000SumR.pdf - p.21
Skin rash grade 4, 0.5%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources: Page: 204114Orig1s000SumR.pdf - p.21
unhealthy, median age 55 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 55 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000SumR.pdf - p.21
Detachment of retinal pigment epithelium 0.5%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 55 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 55 years
Sex: M+F
Population Size: 211
Sources:
Retinal vein occlusion 0.6%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 55 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 55 years
Sex: M+F
Population Size: 211
Sources:
Interstitial lung disease 2.4%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 55 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 55 years
Sex: M+F
Population Size: 211
Sources:
Skin rash 6%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 55 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 55 years
Sex: M+F
Population Size: 211
Sources:
Cardiomyopathy 7%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources: Page: 204114Orig1s000SumR.pdf - p.21
unhealthy, median age 55 years
n = 211
Health Status: unhealthy
Condition: melanoma
Age Group: median age 55 years
Sex: M+F
Population Size: 211
Sources: Page: 204114Orig1s000SumR.pdf - p.21
Central serous retinopathy grade 2
DLT
10 mg 1 times / day multiple, oral
Highest studied dose
Dose: 10 mg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 4
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 4
Sources:
Diarrhoea grade 3
DLT
10 mg 1 times / day multiple, oral
Highest studied dose
Dose: 10 mg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 4
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 4
Sources:
Rash grade 3
DLT
10 mg 1 times / day multiple, oral
Highest studied dose
Dose: 10 mg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 4
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 4
Sources:
Detachment of retinal pigment epithelium 28%
10 mg 1 times / day multiple, oral
Highest studied dose
Dose: 10 mg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 4
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 4
Sources:
Central serous retinopathy grade 2
DLT
4 mg 1 times / day multiple, oral
Highest studied dose
Dose: 4 mg, 1 times / day
Route: oral
Route: multiple
Dose: 4 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 3
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 3
Sources:
Fatigue 8.3%
Disc. AE
3 mg 1 times / day multiple, oral
MTD
unhealthy, median age 58.5 years
n = 12
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 12
Sources:
Thrombocytopenia grade 1, 1%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Pruritus grade 1, 14%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Fissures of skin grade 1, 16%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Fatigue grade 1, 19%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Nausea grade 1, 20%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Peripheral oedema grade 1, 26%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Constipation grade 1, 3%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Dry mouth grade 1, 3%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Left ventricular ejection fraction decreased grade 1, 3%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Diarrhoea grade 1, 34%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Mucosal inflammation grade 1, 4%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Acneiform dermatitis grade 1, 49%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Periorbital oedema grade 1, 7%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Vomiting grade 1, 7%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Decreased appetite grade 1, 9%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Eye disorders NEC grade 1, 9%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Constipation grade 2, 1%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Decreased appetite grade 2, 1%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Diarrhoea grade 2, 10%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Fatigue grade 2, 10%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Peripheral oedema grade 2, 3%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Acneiform dermatitis grade 2, 31%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Vomiting grade 2, 4%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Fissures of skin grade 2, 6%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Left ventricular ejection fraction decreased grade 2, 6%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Nausea grade 2, 6%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Pruritus grade 2, 6%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Diarrhoea grade 3, 1%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Eye disorders NEC grade 3, 1%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Fatigue grade 3, 1%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Left ventricular ejection fraction decreased grade 3, 1%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Vomiting grade 3, 1%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Acneiform dermatitis grade 3, 4%
2 mg 1 times / day multiple, oral
Recommended
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 70
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 70
Sources:
Rash grade 3
DLT
2 mg 1 times / day multiple, oral
Dose: 2 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2 mg, 1 times / day
Sources:
unhealthy, median age 58.5 years
n = 3
Health Status: unhealthy
Condition: advanced solid tumour
Age Group: median age 58.5 years
Sex: M+F
Population Size: 3
Sources:
OverviewDrug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
no
no
no
no
no
yes [EC50 2.7 uM]
no (co-administration study)
Comment: Based on cross-study comparisons, oral administration of trametinib 2 mg QD with everolimus (sensitive CYP3A4 substrate) 5 mg QD had no clinically important effect on the exposure (AUC and Cmax) of everolimus.
Page: -
yes [IC50 0.34 uM]
yes [IC50 0.94 uM]
yes [IC50 1.1 uM]
yes [IC50 1.3 uM]
yes [IC50 4.1 uM]
yes [IC50 5 uM]
yes [IC50 5.5 uM]
Drug as victimTox targets

Tox targets

PubMed

PubMed

TitleDatePubMed
Antitumor activities of JTP-74057 (GSK1120212), a novel MEK1/2 inhibitor, on colorectal cancer cell lines in vitro and in vivo.
2011 Jul
GSK1120212 (JTP-74057) is an inhibitor of MEK activity and activation with favorable pharmacokinetic properties for sustained in vivo pathway inhibition.
2011 Mar 1
Combination small molecule MEK and PI3K inhibition enhances uveal melanoma cell death in a mutant GNAQ- and GNA11-dependent manner.
2012 Aug 15
Trametinib (GSK1120212) in the treatment of melanoma.
2013 Apr
MEK and the inhibitors: from bench to bedside.
2013 Apr 12
Patents

Sample Use Guides

Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with MEKINIST. The recommended dosage regimens of MEKINIST are 2 mg orally once daily as a single agent or in combination with dabrafenib 150 mg orally twice daily.Take MEKINIST at least 1 hour before or at least 2 hours after a meal.
Route of Administration: Oral
A375 and SK-MEL-28 untransfected or transfected with Mcl-1 plasmid were treated with 2 nM trametinib for 72 hours. The cell survival was evaluated by sulforhodamine B assay.
Name Type Language
TRAMETINIB
DASH   INN   USAN   VANDF   WHO-DD  
INN   USAN  
Official Name English
TRAMETINIB [MI]
Common Name English
JTP 74057
Code English
JTP-74057
Code English
TMT-212
Code English
TMT212
Code English
TRAMETINIB [VANDF]
Common Name English
N-(3-(3-CYCLOPROPYL-5-((2-FLUORO-4-IODOPHENYL)AMINO)-6,8-DIMETHYL-2,4,7-TRIOXO-3,4,6,7-TETRAHYDROPYRIDO(4,3-D)PYRIMIDIN-1(2H)-YL)PHENYL)ACETAMIDE
Systematic Name English
TRAMETINIB [USAN]
Common Name English
GSK1120212
Code English
TRAMETINIB [WHO-DD]
Common Name English
GSK-1120212
Code English
ACETAMIDE, N-(3-(3-CYCLOPROPYL-5-((2-FLUORO-4-IODOPHENYL)AMINO)-3,4,6,7-TETRAHYDRO-6,8- DIMETHYL-2,4,7-TRIOXOPYRIDO(4,3-D)PYRIMIDIN-1(2H)-YL)PHENYL)-
Systematic Name English
TRAMETINIB [INN]
Common Name English
Classification Tree Code System Code
NCI_THESAURUS C69145
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
NCI_THESAURUS C129825
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
FDA ORPHAN DRUG 376812
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
WHO-ATC L01XE25
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
EMA ASSESSMENT REPORTS MEKINIST (AUTHORIZED: MELANOMA)
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
FDA ORPHAN DRUG 495915
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
WHO-VATC QL01XE25
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
FDA ORPHAN DRUG 521616
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
FDA ORPHAN DRUG 325410
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
NDF-RT N0000175605
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
Code System Code Type Description
WIKIPEDIA
TRAMETINIB
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
PRIMARY
FDA UNII
33E86K87QN
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
PRIMARY
EVMPD
SUB119776
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
PRIMARY
INN
9421
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
PRIMARY
PUBCHEM
11707110
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
PRIMARY
NCI_THESAURUS
C77908
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
PRIMARY
LACTMED
Trametinib
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
PRIMARY
DRUG CENTRAL
4802
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
PRIMARY
MERCK INDEX
M11718
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
PRIMARY
ChEMBL
CHEMBL2103875
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
PRIMARY
DRUG BANK
DB08911
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
PRIMARY
RXCUI
1425099
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
PRIMARY RxNorm
IUPHAR
6495
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
PRIMARY
CAS
871700-17-3
Created by admin on Sat Jun 26 08:57:09 UTC 2021 , Edited by admin on Sat Jun 26 08:57:09 UTC 2021
PRIMARY