Adverse reactions (ARs) and laboratory abnormalities occurring in ≥15% of patients on IMBRUVICA® + rituximab

E1912 Trial

Median exposure to IMBRUVICA® + rituximab was 34.3 months vs 4.7 months for FCR1

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 IR (n=352)FCR (n=158)
Adverse Drug Reaction TermAll Grades (%)Grade 3 or Higher* (%)All Grades (%)Grade 3 or Higher* (%)
General disorders and administration site conditions 
Fatigue802783
Peripheral edema281170
Pyrexia271271
Pain23280
Musculoskeletal and connective tissue disorders 
Musculoskeletal pain615352
Arthralgia415101
Gastrointestinal disorders 
Diarrhea534271
Nausea401641
Stomatitis22181
Abdominal pain192101
Vomiting182280
Constipation170320
Hematology abnormalities 
Neutrophils decreased53307044
Peripheral edema4376925
Hemoglobin decreased260512
Skin and subcutaneous tissue disorders 
Rash494295
Bruising36141
Vascular disorders 
Hypertension4219226
Hemorrhage31281
Nervous system disorders 
Headache401271
Dizziness211131
Peripheral neuropathy191131
Chemistry abnormalities 
Creatinine increased381171
Bilirubin increased302150
AST increased25323<1
Respiratory, thoracic, and mediastinal disorders 
Cough320250
Dyspnea222211
Infections and infestations 
Upper respiratory tract infection291192
Skin infection16131
Metabolism and nutrition disorders 
Hyperuricemia19140
Decreased appetite150201
Psychiatric disorders 
Insomnia161191

*For laboratory abnormalities (hematology abnormalities and chemistry abnormalities), this column shows abnormalities that were Grades 3-4.

Includes multiple adverse drug reaction terms.

Based on laboratory measurements per 2008 iwCLL criteria.