ASH Clinical News ACN_5.4s_March_supplement_web - Page 8

IMBRUVICA ® (ibrutinib) Table 5: Adverse Reactions Reported in ≥ 10% of Patients and at Least 2% Greater in the IMBRUVICA Treated Arm in Patients with CLL/SLL in RESONATE (continued) IMBRUVICA Ofatumumab (N=195) (N=191) All Grades Grade 3 or 4 All Grades Grade 3 or 4 (%) (%) (%) (%) Body System Adverse Reaction Musculoskeletal and connective tissue disorders Musculoskeletal 28 2 18 1 pain* Arthralgia 17 1 7 0 Nervous system disorders Headache 14 1 6 0 Dizziness 11 0 5 0 Injury, poisoning and procedural complications Contusion 11 0 3 0 Eye disorders Vision blurred 10 0 3 0 Subjects with multiple events for a given ADR term are counted once only for each ADR term. The body system and individual ADR terms are sorted in descending frequency order in the IMBRUVICA arm. * Includes multiple ADR terms Table 6: Treatment-Emergent Hematologic Laboratory Abnormalities in Patients with CLL/SLL in RESONATE IMBRUVICA Ofatumumab (N=195) (N=191) All Grades Grade 3 or 4 All Grades Grade 3 or 4 (%) (%) (%) (%) Neutrophils 51 23 57 26 Decreased Platelets 52 5 45 10 Decreased Hemoglobin 36 0 21 0 Decreased RESONATE-2: Adverse reactions described below in Table 7 reflect exposure to IMBRUVICA with a median duration of 17.4 months. The median exposure to chlorambucil was 7.1 months in RESONATE-2. Table 7: Adverse Reactions Reported in ≥ 10% of Patients and at Least 2% Greater in the IMBRUVICA Treated Arm in Patients with CLL/SLL in RESONATE-2 IMBRUVICA Chlorambucil (N=135) (N=132) Body System All Grades Grade 3 or 4 All Grades Grade 3 or 4 Adverse Reaction (%) (%) (%) (%) Gastrointestinal disorders Diarrhea 42 4 17 0 Stomatitis* 14 1 4 1 Musculoskeletal and connective tissue disorders Musculoskeletal 36 4 20 0 pain* Arthralgia 16 1 7 1 Muscle spasms 11 0 5 0 Eye disorders Dry eye 17 0 5 0 Lacrimation 13 0 6 0 increased Vision blurred 13 0 8 0 Visual acuity 11 0 2 0 reduced IMBRUVICA ® (ibrutinib) Table 7: Adverse Reactions Reported in ≥ 10% of Patients and at Least 2% Greater in the IMBRUVICA Treated Arm in Patients with CLL/SLL in RESONATE-2 (continued) IMBRUVICA Chlorambucil (N=135) (N=132) All Grades Grade 3 or 4 All Grades Grade 3 or 4 Body System (%) (%) (%) (%) Adverse Reaction Skin and subcutaneous tissue disorders Rash* 21 4 12 2 Bruising* 19 0 7 0 Infections and infestations Skin infection* 15 2 3 1 Pneumonia* 14 8 7 4 Urinary tract 10 1 8 1 infections Respiratory, thoracic and mediastinal disorders Cough 22 0 15 0 General disorders and administration site conditions Peripheral edema 19 1 9 0 Pyrexia 17 0 14 2 Vascular disorders Hypertension* 14 4 1 0 Nervous system disorders Headache 12 1 10 2 Subjects with multiple events for a given ADR term are counted once only for each ADR term. The body system and individual ADR terms are sorted in descending frequency order in the IMBRUVICA arm. * Includes multiple ADR terms HELIOS: Adverse reactions described below in Table 8 reflect exposure to IMBRUVICA + BR with a median duration of 14.7 months and exposure to placebo + BR with a median of 12.8 months in HELIOS in patients with previously treated CLL/SLL. Table 8: Adverse Reactions Reported in at Least 10% of Patients and at Least 2% Greater in the IMBRUVICA Arm in Patients with CLL/SLL in HELIOS Ibrutinib + BR Placebo + BR (N=287) (N=287) Body System All Grades Grade 3 or 4 All Grades Grade 3 or 4 Adverse Reaction (%) (%) (%) (%) Blood and lymphatic system disorders Neutropenia* 66 61 60 55 Thrombocytopenia* 34 16 26 16 Skin and subcutaneous tissue disorders Rash* 32 4 25 1 Bruising* 20 <1 8 <1 Gastrointestinal disorders Diarrhea 36 2 23 1 Abdominal pain 12 1 8 <1 Musculoskeletal and connective tissue disorders Musculoskeletal 29 2 20 0 pain* Muscle spasms 12 <1 5 0 General disorders and administration site conditions Pyrexia 25 4 22 2