Table 3: ADRs occurring in patients treated with vemurafenib in the phase II or phase III study and events originating from safety reports across all trials* and post-marketing sources#.

System organ class
 Very Common
 Common
 Uncommon
 Rare
 
Infections and infestations
   Folliculitis
    
Neoplasms benign, malignant and unspecified (including cysts and polyps)
 SCC of the skin (c), seborrheic keratosis, skin papilloma
 Basal cell carcinoma, new primary melanoma+
 Non-cuSCC*+
 Chronic myelomonocytic leukaemia#§
 
Metabolism and nutrition disorders
 Decreased appetite
      
Nervous system disorders
 Headache, dysgeusia
 7th nerve paralysis, dizziness
 Neuropathy peripheral
  
Eye disorders
   Uveitis
 Retinal vein occlusion
  
Vascular disorders
     Vasculitis
  
Respiratory, thoracic and mediastinal disorders
 Cough
      
Gastrointestinal disorders
 Diarrhoea, vomiting, nausea, constipation
      
Skin and subcutaneous tissue disorders
 Photosensitivity reaction, actinic keratosis, rash, rash maculo-papular, rash papular, pruritus, hyperkeratosis, erythema, alopecia, dry skin, sunburn
 Palmar-plantar erythrodysaesthesia syndrome, panniculitis (including erythema nodosum), keratosis pilaris
 Toxic epidermal necrolysis (d), Stevens-Johnson syndrome (e)
 Drug reaction with eosinophilia and systemic symptoms*#
 
Musculoskeletal and connective tissue disorders
 Arthralgia, myalgia, pain in extremity, musculoskeletal pain, back pain
 Arthritis
    
General disorders and administration site conditions
 Fatigue, pyrexia, oedema peripheral, asthenia
      
Investigations
 GGT increase (b)
 ALT increase (b), alkaline phosphatase increase (b), bilirubin increase (b), weight decreased, QT prolongation
 AST increase (b)

* Events originating from safety reports across all trials

# Events originating from post-marketing sources.

§ Pre-existing chronic myelomonocytic leukaemia with NRAS mutation.

+ A causal relationship between the medicinal product and the adverse event is at least a reasonable possibility.

Description of selected adverse reactions

Hepatic enzyme increase (b)

Liver enzyme abnormalities reported in the phase III clinical study are expressed below as the proportion of patients who experienced a shift from baseline to a grade 3 or 4 liver enzyme abnormalities:

• Very common: GGT

• Common: ALT, alkaline phosphatase, bilirubin

• Uncommon: AST

There were no increases to Grade 4 ALT, alkaline phosphatase or bilirubin.

Cutaneous squamous cell carcino