Table 3.

Treatment-emergent adverse reactions in the safety populationa

Preferred termbAny gradeGrade ≥ 3
Pyrexia131 (62%)14 (7%)
Headache77 (36%)7 (3%)
Edema63 (30%)3 (1%)
Febrile neutropenia53 (25%)48 (23%)
Nausea52 (25%)0
Hypokalemia48 (23%)13 (6%)
Rash45 (21%)5 (2%)
Constipation43 (20%)1 (<1%)
Tremor42 (20%)3 (1%)
Diarrhea42 (20%)3 (1%)
Neutropenia40 (19%)37 (17%)
Abdominal pain40 (19%)5 (2%)
Anemia40 (19%)28 (13%)
Cough39 (18%)0
Fatigue37 (17%)2 (1%)
Arrhythmia37 (17%)4 (2%)
Hypertransaminasemia32 (15%)15 (7%)
Dyspnea32 (15%)11 (5%)
Chills31 (15%)0
Insomnia31 (15%)0
Dizziness30 (14%)1 (<1%)
Back pain29 (14%)4 (2%0
Thrombocytopenia29 (14%)21 (10%)
Vomiting28 (13%)0
Immunoglobulins decreased27 (13%)3 (1%)
Hypotension26 (12%)7 (3%)
Pain in extremity26 (12%)2 (1%)
Cytokine release syndrome26 (12%)5 (2%)
Hypomagnesemia25 (12%)0
Weight increased23 (11%)0
Bone pain23 (11%)6 (3%)
Chest pain23 (11%)2 (1%)
Hyperglycemia22 (10%)13 (6%)
Altered state of consciousness22 (10%)3 (1%)
Hyperbilirubinemia22 (10%)11 (5%)
Arthralgia21 (10%)4 (2%)
Decreased appetite21 (10%)6 (3%)
  • aN = 212 adults with R/R ALL treated with blinatumomab using the fixed 9→28 μg or the BSA-based 5→15 μg/m2 step-dose regimens.

  • bGrouped terms. See Supplementary Table S1 for further information.