) was eva luated in 257 patients with BRAF V600 mutant unresectable or metastatic melanoma (hereafter referred to as the Combo 300 population), based on the Phase III study (CMEK162B2301, Part 2). The most common adverse reactions (>25%) occurring in patients treated with encorafenib 300 mg administered with binimetinib were fatigue, nausea and diarrhoea.
Tabulated list of adverse reactions
Adverse reactions are listed below by MedDRA body system organ class and the following frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 3: Adverse reactions occurring in patients receiving binimetinib in combination with encorafenib at the recommended dose (n = 274)
System Organ Class
Adverse reaction
Frequency (All grades)
Neoplasms benign, malignant and unspecified
Cutaneous squamous cell carcinomaa
Common
Basal cell carcinoma*
Common
Skin papilloma*
Common
Blood and lymphatic system disorders
Anaemia
Very common
Immune system disorders
Hypersensitivityb
Common
Nervous system disorders
Neuropathy peripheral*
Very common
Dizziness*
Very common
Headache*
Very common
Dysgeusia
Common
Facial paresisc
Uncommon
Eye disorders
Visual impairment*
Very common
RPED*
Very common
Uveitis*
Common
Cardiac disorders
Left ventricular dysfunctiond
Common
Vascular disorders
Haemorrhagee
Very common
Hypertension*
Very common
Venous thromboembolismf
Common
Gastrointestinal disorders
Abdominal pain*
Very common
Diarrhoea*
Very common
Vomiting*
Very common
Nausea
Very common
Constipation
Very common
Colitisg
Common
Pancreatitis*
Uncommon
Skin and subcutaneous tissue disorders
Hyperkeratosis *
Very common
Rash *
Very common
Dry skin*
Very common
Pruritus*
Very common
Alopecia*
Very common
Photosensitivity*
Common
Dermatitis acneiform*
Common
Palmar-plantar erythrodysaesthesia syndrome (PPES)
Common
Erythema*
Common
Panniculitis*
Common
Musculoskeletal and connective tissue disorders
Arthralgia*
Very common
Muscular disorders/Myalgiah
Very common
Back pain
Very common
Pain in extremity
Very common
Rhabdomyolysis
Uncommon
Renal and urinary disorders
Renal failure*
Common
General disorders and administration site conditions
Pyrexia*
Very common
Peripheral oedema i
Very common
Fatigue*
Very common
Investigations
Blood creatine phosphokinase increased
Very Common
Transaminase increased*
Very Common
Gamma-glutamyl transferase increased*
Very Common
Blood creatinine increased*
Common
Blood alkaline phosphatase increased
Common
Amylase increased
Common
