Table 16: Incidence of VELCADE Adverse Drug Reactions reported in 10% of patients in the ≥ Phase 3 Relapsed Multiple Myeloma Study comparing VELCADE IV and SC ---- IV ------- ---- SC -------------- (N=74) (N=147) MedDRA System Total Total Class n (%) n (%) ---- Preferred Term n 3 n 3 ≥ ≥ (%) 4 (%) 4 Blood and lymphatic system disorders Anaemia 26 6 53 14 (35) (8) 0 (36) (3) Leukopenia 16 4 29 9 (22) (5) 1 (20) (6) 0 (1) Neutropenia 20 10 42 22 (27) (29) (4) (3) 27 8 52 12 Thrombocytopenia (36) (35) (8) 7 (8) (5) Gastrointestinal disorders Abdominal pain 8 0 5 1 (11) 0 (3) (1) 0 Abdominal pain 8 0 3 0 upper (11) 0 (2) 0 Constipation 11 1 21 1 (15) (1) 0 (14) (1) 0 Diarrhoea 27 3 35 2 (36) (4) 1 (24) (1) 1 (1) (1) Nausea 14 0 27 0 (19) 0 (18) 0 Vomiting 0 3 12 17 (2) (16) 1 (12) 0 (1) General disorders and administration site conditions Asthenia 14 4 23 3 (19) (5) 0 (16) (2) 0 Fatigue 15 3 17 3 (20) (4) 0 (12) (2) 0 Pyrexia 12 0 28 0 (16) 0 (19) 0 Infections and infestations Herpes zoster 7 1 16 2 (9) (1) 0 (11) (1) 0 Metabolism and nutrition disorders
Table 16: Incidence of VELCADE Adverse Drug Reactions reported in ≥ 10% of patients in the Phase 3 Relapsed Multiple Myeloma Study comparing VELCADE IV and SC IV SC (N=74) (N=147) MedDRA System Class Total ---- n (%) ---- Total ---- n (%) Preferred Term n (%) 3 ≥ 4 n (%) 3 ≥ 4 Blood and lymphatic system disorders Anaemia 26 (35) 6 (8) 0 53 (36) 14 (3) Leukopenia 16 (22) 4 (5) 1 (1) 29 (20) 9 (6) 0 Neutropenia 20 (27) 10 (4) 42 (29) 22 (3) Thrombocytopenia 27 (36) 8 (8) 52 (35) 12 (8) 7 (5) Gastrointestinal disorders Abdominal pain 8 (11) 0 0 5 (3) 1 (1) 0 Abdominal pain upper 8 (11) 0 0 3 (2) 0 0 Constipation 11 (15) 1 (1) 0 21 (14) 1 (1) 0 Diarrhoea 27 (36) 3 (4) 1 (1) 35 (24) 2 (1) 1 (1) Nausea Vomiting 14 (19) 12 (16) 0 0 0 1 (1) 27 (18) 17 (12) 0 3 (2) 0 0 General disorders and administration site conditions Asthenia 14 (19) 4 (5) 0 23 (16) 3 (2) 0 Fatigue 15 (20) 3 (4) 0 17 (12) 3 (2) 0 Pyrexia 12 (16) 0 0 28 (19) 0 0 Infections and infestations Herpes zoster 7 (9) 1 (1) 0 16 (11) 2 (1) 0 Metabolism and nutrition disorders -------------- -------
auspar-bortezomib-130116-pi.docx