6: Incidence of adverse drug reactions (≥10%) reported in patients treated with STIVARGA and reported more commonly than in patients receiving placebo (GRID) STIVARGA plus BSC§ Placebo plus BSC§ (N=132) (N=66) System Organ Grade Grade Class/Preferred Term All All ≥3 ≥3 % % % % General disorders and administration site conditions Asthenia/Fatigue 52 4 39 2 Mucosal inflammation 17 2 2 0 Pain 24 2 21 5 Fever 21 0 11 2 Metabolism and nutrition disorders Decreased appetite 31 <1 21 3 and food intake Hypothyroidism 13 0 3 0 Skin and subcutaneous tissue disorders HFSR/PPE 67 22 15 2 Rash 30 7 3 0 Alopecia 24 2 2 0 Gastrointestinal disorders Diarrhoea 47 8 9 0 Stomatitis 25 0 6 2 Nausea 20 2 12 2 Vomiting 17 <1 8 0 Investigations Weight loss 14 0 8 0 Infections and infestations Infection 32 5 5 0 Vascular disorders Hypertension 59 28 27 5 Haemorrhage* 11 4 3 0 Respiratory, thoracic and mediastinal disorders Dysphonia 39 0 9 0 Nervous system disorders Headache 16 0 9 0 Musculoskeletal and connective tissue disorders Musculoskeletal 14 0 3 0
6: Incidence of adverse drug reactions (≥10%) reported in patients treated with STIVARGA and reported more commonly than in patients receiving placebo (GRID) System Organ Class/Preferred Term STIVARGA plus BSC§ (N=132) Placebo plus BSC§ (N=66) Grade Grade All % ≥3 % All % ≥3 % General disorders and administration site conditions Asthenia/Fatigue Mucosal inflammation Pain Fever 52 17 24 21 4 2 2 0 39 2 21 11 2 0 5 2 Metabolism and nutrition disorders Decreased appetite and food intake Hypothyroidism 31 13 <1 0 21 3 3 0 Skin and subcutaneous tissue disorders HFSR/PPE Rash Alopecia 67 30 24 22 7 2 15 3 2 2 0 0 Gastrointestinal disorders Diarrhoea Stomatitis Nausea Vomiting 47 25 20 17 8 0 2 <1 9 6 12 8 0 2 2 0 Investigations Weight loss 14 0 8 0 Infections and infestations Infection 32 5 5 0 Vascular disorders Hypertension Haemorrhage* 59 11 28 4 27 3 5 0 Respiratory, thoracic and mediastinal disorders Dysphonia 39 0 9 0 Nervous system disorders Headache 16 0 9 0 Musculoskeletal and connective tissue disorders Musculoskeletal 14 0 3 0
auspar-regorafenib-151119-pi.docx