45 As above - also temporary sedation, slight alopecia*, slight conjunctivitis * , decreased leukocyte counts and anemia (2/8).

% % % % % % Metabolism and nutrition disorders Decreased Common 4 0 Common 8 < 1 < 1 0 appetite * Nervous system disorders Headache Very 16 1 Very 15 1 2 < 1 common common Gastrointestinal disorders Nausea Very 14 < 1 Very 20 < 1 < 1 < 1 common common Constipation Common 10 0 Very 12 < 1 < 1 0 common Diarrhoea Common 8 < 1 Very 11 2 2 < 1 common Vomiting Common 6 0 Very 10 < 1 < 1 0 common Upper Common 10 1 Common 5 < 1 < 1 0 abdominal pain Abdominal Common 6 0 Common 6 < 1 < 1 < 1 pain Dyspepsia Common 5 0 Common 3 0 0 0 Skin and subcutaneous tissue disorders Rash Very 33 < 1 Very 28 1 2 0 common common Pruritus Very 18 < 1 Very 24 < 1 < 1 0 common common Alopecia Very 10 0 ...[+++] Common 9 0 0 0 common Dry skin Very 10 0 Common 5 0 0 0 common Erythema Common 3 0 Common 5 < 1 < 1 0 Musculoskeletal and connective tissue disorders Myalgia Very 10 < 1 Very 10 < 1 < 1 < 1 common common Arthralgia Common 8 < 1 Common 7 < 1 1 0 Muscle spasms Common 9 0 Common 8 < 1 < 1 0 Bone pain Common 4 0 Common 6 < 1 < 1 0

Alopecia, muscle spasms, decreased appetite, arthralgia, abdominal pain, bone pain, peripheral oedema, asthenia, upper abdominal pain, dry skin, erythema and pain in extremity were observed less commonly (< 10% and ≥5%) and have been of mild to moderate severity (Grade 1 or 2).

Skin and subcutaneous tissue disorders Uncommon: Alopecia, purpura, skin discolouration, hyperhidrosis Very rare: Angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, photosensitivity

constipation, oral soft tissue disorder Uncommon pancreatitis, upper gastrointestinal ulcer, oesophagitis, ascites*, anal fissure, dysphagia Rare protein-losing gastroenteropathy, ileus Not known fatal gastrointestinal haemorrhage* Hepatobiliary disorders Uncommon hepatitis, cholecystitis, cholestasis Skin and subcutaneous tissue disorders Very common skin rash d Common alopecia, dermatitis (including eczema), pruritus, acne, dry skin, urticaria, hyperhidrosis Uncommon acute febrile neutrophilic dermatosis, photosensitivity, pigmentation disorder, panniculitis, skin ulcer, bullous conditions, nail disorder, palmar-plantar erythrodysesthe ...[+++]sia syndrome Musculoskeletal and connective tissue disorders Very common musculoskeletal pain Common arthralgia, myalgia, muscular weakness, musculoskeletal stiffness, muscle spasm Uncommon rhabdomyolysis, muscle inflammation, tendonitis Renal and urinary disorders Uncommon renal failure, urinary frequency, proteinuria Reproductive system and breast disorders Uncommon gynecomastia, irregular menstruation General disorders and administration site conditions Very common fluid retention*, fatigue, superficial oedema* e , pyrexia Common asthenia, pain, chest pain, generalised oedema*, chills Uncommon malaise, temperature intolerance Investigations Common weight decreased, weight increased Uncommon blood creatine phosphokinase increased Injury, poisoning, and procedural complications Common contusion

The most frequent (≥10%) non-haematological adverse reactions were rash, pruritus, headache, nausea, fatigue, alopecia and myalgia.