0
Vomiting 18 2
Abdominal pain 14 0
Dyspepsia 12 0
Infections and infestations Upper respiratory tract infection 47 2
Sinusitis 22 6
Skin infection 16 6
Pneumonia 12 10
Urinary tract infection 12 2
General disorders and administration site conditions Fatigue 33 6
Pyrexia 24 2
Peripheral edema 22 0
Asthenia 14 6
Chills 12 0
Skin and subcutaneous tissue disorders Bruising 51 2
Rash 25 0
Petechiae 16 0
Respiratory, thoracic and mediastinal disorders Cough 22 0
Oropharyngeal pain 14 0
Dyspnea 12 0
Musculoskeletal and connective tissue disorders Musculoskeletal pain 25 6
Arthralgia 24 0
Muscle spasms 18 2
Nervous system disorders Dizziness 20 0
Headache 18 2
Metabolism and nutrition disorders Decreased appetite 16 2
Neoplasms benign, malignant, unspecified Second malignancies* 12* 0
Vascular disorders Hypertension 16 8
Table 4: Treatment-Emergent* Hematologic Laboratory Abnormalities in Patients with CLL/SLL (N=51) in Study 1102
Percent of Patients (N=51)
All Grades (%) Grade 3 or 4 (%)
* Based on laboratory measurements per IWCLL criteria and adverse reactions.
Platelets Decreased 69 12
Neutrophils Decreased 53 26
Hemoglobin Decreased 43 0
RESONATE
Adverse reactions and laboratory abnormalities described below in TABLES 5 and 6 reflect exposure to IMBRUVICA with a median duration of 8.6 months and exposure to ofatumumab with a median of 5.3 months in RESONATE in patients with previously treated CLL/SLL.
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
Body System
Adverse Reaction IMBRUVICA
(N=195) Ofatumumab
(N=191)
All Grades
(%) Grade 3 or 4
(%) All Grades
(%) Grade 3 or 4
(%)
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
Gastrointestinal disorders
Diarrhea 48 4 18 2
Nausea 26 2 18 0
Stomatitis* 17 1 6 1
Constipation 15 0 9 0
Vomiting 14 0 6 1
General disorders and administration site conditions
Pyrexia 24 2 15 1
Infections and infestations
Upper respiratory tract infection 16 1 11 2
Pneumonia* 15 10 13 9
Sinusitis* 11 1 6 0
Urinary tract infection 10 4 5 1
Skin and subcutaneous tissue disorders
Rash* 24 3&nb |
