sp;13 0
Petechiae 14 0 1 0
Bruising* 12 0 1 0
Musculoskeletal and connective tissue disorders
Musculoskeletal pain* 28 2 18 1
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
Table 6: Treatment-Emergent Hematologic Laboratory Abnormalities in Patients with CLL/SLL in RESONATE
IMBRUVICA
(N=195) Ofatumumab
(N=191)
All Grades
(%) Grade 3 or 4
(%) All Grades
(%) Grade 3 or 4
(%)
Neutrophils Decreased 51 23 57 26
Platelets Decreased 52 5 45 10
Hemoglobin Decreased 36 0 21 0
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
Body System
Adverse Reaction IMBRUVICA
(N=135) Chlorambucil
(N=132)
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 42 4 17 0
Stomatitis* 14 1 4 1
Musculoskeletal and connective tissue disorders
Musculoskeletal pain* 36 4 20 0
Arthralgia 16 1 7 1
Muscle spasms 11 0 5 0
Eye disorders
Dry eye 17 0 5 0
Lacrimation increased 13 0 6 0
Vision blurred 13 0 8 0
Visual acuity reduced 11 0 2 0
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 infections 10 1 8 1
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
Hy |
