ARs in ≥10% of patients in the IMBRUVICA® arm in patients with CLL/SLL1

RESONATE™ Trial

Median duration of exposure was 8.6 months for IMBRUVICA® vs 5.3 months for ofatumumab1

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 IMBRUVICA® (n=195)Ofatumumab (n=191)
Adverse ReactionsAll Grades (%)Grade 3 or Higher (%)All Grades (%)Grade 3 or Higher (%)
Gastrointestinal disorders 
Diarrhea484182
Nausea262180
Stomatitis*17161
Constipation15090
Vomiting14061
Musculoskeletal and connective tissue disorders 
Musculoskeletal pain*282181
Arthralgia17170
Muscle spasms13080
Skin and subcutaneous tissue disorders 
Rash*243130
Petechiae14010
Bruising*12010
General disorders and administration site conditions 
Pyrexia242152
Respiratory, thoracic and mediastinal disorders 
Cough190231
Dyspnea122101
Infections and infestations 
Upper respiratory tract infection161112
Pneumonia*15121310
Sinusitis*11160
Urinary tract infection10451
Nervous system disorders 
Headache14160
Dizziness11050
Injury, poisoning and procedural complications 
Contusion11030
Eye disorders 
Vision blurred10030

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

Includes multiple ADR terms.

Includes 3 events of pneumonia with fatal outcome in each arm, and 1 event of pyrexia and upper respiratory tract infection with a fatal outcome in the ofatumumab arm.