Table 9: Non-Hematologic Adverse Reactions in ≥ 10% in Patients with WM in Study 1118 (N=63)
Body System Adverse Reaction All Grades
(%) Grade 3 or 4
(%)
The body system and individual ADR preferred terms are sorted in descending frequency order.
* Includes multiple ADR terms.
Gastrointestinal disorders Diarrhea 37 0
Nausea 21 0
Stomatitis* 16 0
Gastroesophageal reflux disease 13 0
Skin and subcutaneous tissue disorders Rash* 22 0
Bruising* 16 0
Pruritus 11 0
General disorders and administrative site conditions Fatigue 21 0
Musculoskeletal and connective tissue disorders Muscle spasms 21 0
Arthropathy 13 0
Infections and infestations Upper respiratory tract infection 19 0
Sinusitis 19 0
Pneumonia* 14 6
Skin infection* 14 2
Respiratory, thoracic and mediastinal disorders Epistaxis 19 0
Cough 13 0
Nervous system disorders Dizziness 14 0
Headache 13 0
Neoplasms benign, malignant, and unspecified (including cysts and polyps) Skin cancer* 11 0
Table 10: Treatment-Emergent Hematologic Laboratory Abnormalities in Patients with WM in Study 1118 (N=63)
Percent of Patients (N=63)
All Grades (%) Grade 3 or 4 (%)
Platelets Decreased 43 13
Neutrophils Decreased 44 19
Hemoglobin Decreased 13 8
Study 1121
Adverse reactions and laboratory abnormalities described below in TABLES 11 and 12 reflect exposure to IMBRUVICA with a median duration of 11.6 months in Study 1121.
Table 11: Non-Hematologic Adverse Reactions in ≥ 10% in Patients with MZL in Study 1121 (N=63)
Body System Adverse Reaction All Grades
(%) Grade 3 or 4
(%)
The body system and individual ADR preferred terms are sorted in descending frequency order.
* Includes multiple ADR terms.
Gastrointestinal disorders Diarrhea 43 5
Nausea 25 0
Dyspepsia 19 0
Stomatitis* 17 2
Abdominal pain 16 2
Constipation 14 0
Abdominal pain upper 13 0
Vomiting 11 2
General disorders and administrative site conditions Fatigue 44 6
Peripheral edema 24 2
Pyrexia 17 2
Skin and subcutaneous tissue disorders Bruising * 41 0
Rash* 29 5
Pruritus 14 0
Musculoskeletal and connective tissue disorders Musculoskeletal pain* 40 3
Arthralgia 24 2
Muscle spasms 19 3
Infections and infestations Upper respiratory tract infection 21 0
Sinusitis* 19 0
Bronchitis 11 0
Pneumonia* 11 10
Metabolism and nutrition disorders Decreased appetite 16 2
Hyperuricemia 16 0
Hypoalbuminemia 14 0
Hypokalemia 13 0
Vascular disorders Hemorrhage* 30 0
Hypertension* 14&nb