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. 2018 Jun 28;2(13):1522–1531. doi: 10.1182/bloodadvances.2018019034

Table 1.

Patient characteristics for the safety population

Characteristic Blinatumomab, N = 267 SOC, N = 109
Mean age (range), y 40.7 (18-80) 41.0 (18-76)
Male sex, n (%) 159 (60) 64 (59)
ECOG performance status, n (%)
 0 95 (36) 41 (38)
 1 133 (50) 48 (44)
 2 39 (15) 19 (17)
 Unknown 0 (0) 1 (1)
Key inclusion criteria, n (%)
 Refractory to primary or salvage therapy 112 (42) 43 (39)
 First relapse, first remission <12 mo 76 (28) 30 (28)
 Untreated second or greater relapse* 31 (12) 14 (13)
 Relapsed after alloHSCT* 46 (17) 22 (20)
 No criteria met 2 (1) 0 (0)
Prior alloHSCT, n (%)
 Yes 93 (35) 35 (32)
 No 173 (65) 73 (67)
 Unknown 1 (<1) 1 (1)
First relapse with remission duration <12 mo, n (%)
 Yes 108 (40) 37 (34)
 No 158 (59) 72 (66)
 Unknown 1 (<1) 0 (0)
Salvage status, n (%)
 First 112 (42) 55 (50)
 Second 91 (34) 34 (31)
 Third or later 64 (24) 20 (18)
Bone marrow blasts (central/local), n (%)
 >5% to <10% 9 (3) 4 (4)
 10% to <50% 60 (22) 19 (17)
 ≥50% 198 (74) 86 (79)
Peripheral blasts, n (%)
 0 116 (43) 43 (39)
 1 to 5 × 109/L 70 (26) 40 (37)
 >5 × 109/L 31 (12) 12 (11)
 Unknown 50 (19) 14 (13)
White blood cells at diagnosis, n (%)
 <30 × 109/L 141 (53) 50 (46)
 ≥30 × 109/L 69 (26) 34 (31)
 Unknown 57 (21) 25 (23)
Platelets, mean (range), × 109/L 71.3 (2-454) 93.1 (8-580)
ALT or AST >3× ULN, n (%) 35 (13) 10 (9)
Patients with history of events of clinical interest, n (%)
 Neutropenias 58 (22) 15 (14)
 Thrombocytopenias 76 (28) 34 (31)
 Leukopenias 15 (6) 4 (4)
 Acute and chronic pancreatitis 2 (1) 3 (3)
 Injection and infusion site reaction 1 (<1) 2 (2)

ALT, alanine aminotransferase; AST, aspartate aminotransferase; ECOG, Eastern Cooperative Oncology Group; ULN, upper limit of normal.

*

Patients who met none of the above inclusion criteria.