RESONATE™-2: SUPPORTING AN ESTABLISHED
SAFETY AND TOLERABILITY PROFILE1

Adverse reactions (ARs) reported in ≥10% of patients in the IMBRUVICA®-treated arm in patients with CLL/SLL1

RESONATE™-2 Clinical Trial

Median duration of exposure was 17.4 months for IMBRUVICA® vs 7.1 months for chlorambucil1

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 IMBRUVICA® (n=135)Chlorambucil (n=132)
Adverse ReactionAll Grades (%)Grade 3 or Higher (%)All Grades (%)Grade 3 or Higher (%)
Gastrointestinal disorders 
Diarrhea424170
Nausea221391
Constipation161160
Stomatitis*14141
Vomiting130201
Abdominal pain133111
Dyspepsia11020
Musculoskeletal and connective tissue disorders 
Musculoskeletal pain*364200
Arthralgia16171
Muscle spasms11050
General disorders and administration site conditions 
Fatigue301385
Peripheral edema19190
Pyrexia170142
Respiratory, thoracic, and mediastinal disorders 
Cough220150
Dyspnea101100
Skin and subcutaneous tissue disorders 
Rash*214122
Bruising*19070
Eye disorders 
Dry eye17050
Lacrimation increased13060
Vision blurred13080
Visual acuity reduced11020
Infections and infestations 
Upper respiratory tract infection172172
Skin infection*15231
Pneumonia*14874
Urinary tract infections10181
Vascular disorders 
Hypertension*14410
Nervous system disorders 
Headache121102
Dizziness110121
Investigations 
Weight decreased100120

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.

Treatment-emergent decrease in hematologic measures1

RESONATE™-2 Trial

Median duration of exposure was 17.4 months for IMBRUVICA® vs 7.1 months for chlorambucil1

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 IMBRUVICA® (n=135)Chlorambucil (n=132)
Adverse ReactionAll Grades (%)Grade 3 or Higher (%)All Grades (%)Grade 3 or Higher (%)
Neutrophils Decreased55286731
Platelets Decreased4775814
Hemoglobin Decreased360392

Treatment-emergent Grade 4 thrombocytopenia (1% in the IMBRUVICA® arm vs 3% in the chlorambucil arm) and neutropenia (11% in the IMBRUVICA® arm vs 12% in the chlorambucil arm) occurred in patients. 

Abbreviations

ADR=adverse drug reaction, AR=adverse reaction, CLL=chronic lymphocytic leukemia, SLL=small lymphocytic lymphoma.

Reference

1 IMBRUVICA® (ibrutinib) Prescribing Information.