iLLUMINATE™: SUPPORTING AN ESTABLISHED
SAFETY PROFILE IN CLL/SLL1

Adverse reactions (ARs) in at least 10% of patients in the IMBRUVICA® arm in patients with CLL/SLL1

iLLUMINATE™ Trial

Median duration of exposure was 29.3 months for IMBRUVICA® + obinutuzumab vs 5.1 months for chlorambucil + obinutuzumab1

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 IMBRUVICA® + obinutuzumab (n=113)chlorambucil + obinutuzumab (n=115)
Adverse ReactionsAll Grades (%)Grade 3 or Higher (%)All Grades (%)Grade 3 or Higher (%)
Blood and lymphatic system disorders 
Neutropenia*48396448
Thrombocytopenia*36192811
Anemia174258
Skin and subcutaneous tissue disorders 
Rash*363110
Bruising*32330
Gastrointestinal disorders 
Diarrhea343100
Constipation160121
Nausea120300
Musculoskeletal and connective tissue disorders 
Musculoskeletal pain*331233
Arthralgia221100
Muscle spasms13060
Respiratory, thoracic, and mediastinal disorders 
Cough271120
Injury, poisoning and procedural complications 
Infusion related reaction252588
Vascular disorders 
Hemorrhage*25190
Hypertension*17443
Infections and infestations 
Pneumonia*16994
Upper respiratory tract infection14160
Skin infection*13130
Urinary tract infection12371
Nasopharyngitis12030
Conjunctivitis11020
Metabolism and nutrition disorders 
Hyperuricemia13100
Cardiac disorders 
Atrial fibrillation12500
General disorders and administration site conditions 
Pyrexia192261
Fatigue180172
Peripheral edema12070
Psychiatric disorders 
Insomnia12040

The data are not an adequate basis for comparison of ADR rates between treatment arms.

The body system and individual ADR terms are sorted in descending frequency order in the IMBRUVICA® arm.

Includes multiple ADR terms.

Includes one event with a fatal outcome.

An established safety profile in CLL/SLL1

  • The most common adverse reactions in patients with CLL/SLL receiving IMBRUVICA® (≥30%) were thrombocytopenia, diarrhea, fatigue, musculoskeletal pain, neutropenia, rash, anemia, bruising, and nausea.

Abbreviations

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

Reference

1IMBRUVICA® (ibrutinib) Prescribing Information.