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. 2015 Apr 17;125(26):4024–4031. doi: 10.1182/blood-2014-12-614636

Table 3.

AEs of CTCAE grade 3 or higher (safety population)

System organ class and preferred term Cohort 1: 0.01 mg/kg (n = 3) Cohort 2: 0.04 mg/kg (n = 3) Cohort 3: 0.15 mg/kg (n = 3) Cohort 4: 0.5 mg/kg (n = 6) Cohort 5: 1.5 mg/kg (n = 3) Cohort 6: 4.5 mg/kg (n = 3) Cohort 7: 7 mg/kg (n = 3) Cohort 8: 2 × 4.5 mg/kg (n = 4) Overall (n = 28)
Any AE of CTCAE grade ≥3 0 0 0 1 (16.7) 3 (100.0) 1 (33.3) 2 (66.7) 1 (25.0) 8 (28.6)
Blood and lymphatic disorders
 Anemia 0 0 0 1 (16.7) 0 1 (33.3) 0 0 2 (7.1)
 Hemolytic anemia 0 0 0 1 (16.7) 0 0 0 0 1 (3.6)
 Thrombocytopenia 0 0 0 1 (16.7) 0 0 0 0 1 (3.6)
General disorders
 Multiorgan failure 0 0 0 1 (16.7) 0 0 0 0 1 (3.6)
 Pyrexia 0 0 0 0 1 (33.3) 0 0 0 1 (3.6)
 Thrombosis in device 0 0 0 0 1 (33.3) 0 0 0 1 (3.6)
Infections and infestations
 Bronchitis 0 0 0 0 1 (33.3) 0 0 0 1 (3.6)
 Pneumonia 0 0 0 1 (16.7) 1 (33.3) 0 1 (33.3) 1 (25.0) 4 (14.3)
 Staphylococcal infection 0 0 0 0 0 0 1 (33.3) 0 1 (3.6)
Investigations
 Bilirubin increased 0 0 0 1 (16.7) 0 0 0 0 1 (3.6)
Metabolism and nutrition
 Hypoalbuminemia 0 0 0 1 (16.7) 0 0 0 0 1 (3.6)
Neoplasms
 T-cell lymphoma 0 0 0 0 1 (33.3) 0 0 0 1 (3.6)

Data are presented as n (%) of AEs.