Table 2.

Selected TEAEs by CD22 positivity and CD22 MESF quartiles per central laboratory.

CD22 positivityCD22 MESF
≥90%<90%Q1Q2Q3Q4
TEAEs, n (%)InO (n = 107)SC (n = 85)InO (n = 35)SC (n = 32)InO (n = 30)SC (n = 33)InO (n = 38)SC (n = 27)InO (n = 41)SC (n = 25)InO (n = 33)SC (n = 32)
Any AEs
 Grade 332 (29.9)16 (18.8)10 (28.6)8 (25.0)10 (33.3)7 (21.2)9 (23.7)9 (33.3)12 (29.3)3 (12.0)11 (33.3)5 (15.6)
 Grade 451 (47.7)66 (77.6)23 (65.7)22 (68.8)16 (53.3)25 (75.8)24 (63.2)17 (63.0)21 (51.2)22 (88.0)13 (39.4)24 (75.0)
 Grade 59 (8.4)0001 (3.3)02 (5.3)03 (7.3)03 (9.1)0
 Grade 3–592 (86.0)82 (96.5)33 (94.3)30 (93.8)27 (90.0)32 (97.0)35 (92.1)26 (96.3)36 (87.8)25 (100)27 (81.8)29 (90.6)
 Total104 (97.2)85 (100)35 (100)32 (100)30 (100)33 (100)37 (97.4)27 (100)39 (95.1)25 (100)33 (100)32 (100)
Neutropeniaa
 Grade 320 (18.7)3 (3.5)8 (22.9)3 (9.4)8 (26.7)3 (9.1)5 (13.2)08 (19.5)3 (12.0)7 (21.2)0
 Grade 429 (27.1)37 (43.5)10 (28.6)8 (25.0)9 (30.0)10 (30.3)16 (42.1)8 (29.6)8 (19.5)11 (44.0)6 (18.2)16 (50.0)
 Grade 3–449 (45.8)40 (47.1)18 (51.4)11 (34.4)17 (56.7)13 (39.4)21 (55.3)8 (29.6)16 (39.0)14 (56.0)13 (39.4)16 (50.0)
 Total52 (48.6)43 (50.6)18 (51.4)11 (34.4)17 (56.7)13 (39.4)22 (57.9)8 (29.6)17 (41.5)15 (60.0)14 (42.4)18 (56.3)
Thrombocytopeniaa
 Grade 310 (9.3)9 (10.6)10 (28.6)1 (3.1)7 (23.3)3 (9.1)5 (13.2)06 (14.6)1 (4.0)2 (6.1)6 (18.8)
 Grade 425 (23.4)46 (54.1)12 (34.3)12 (37.5)9 (30.0)13 (39.4)11 (28.9)11 (40.7)10 (24.4)19 (76.0)7 (21.2)15 (46.9)
 Grade 3–435 (32.7)55 (64.7)22 (62.9)13 (40.6)16 (53.3)16 (48.5)16 (42.1)11 (40.7)16 (39.0)20 (80.0)9 (27.3)21 (65.6)
 Total46 (43.0)56 (65.9)23 (65.7)14 (43.8)17 (56.7)16 (48.5)18 (47.4)12 (44.4)18 (43.9)21 (84.0)16 (48.5)21 (65.6)
Febrile neutropeniaa
 Grade 325 (23.4)46 (54.1)9 (25.7)13 (40.6)8 (26.7)14 (42.4)9 (23.7)11 (40.7)11 (26.8)17 (68.0)6 (18.2)17 (53.1)
 Grade 44 (3.7)2 (2.4)2 (5.7)3 (9.4)3 (10.0)3 (9.1)2 (5.3)001 (4.0)1 (3.0)1 (3.1)
 Grade 3–429 (27.1)48 (56.5)11 (31.4)16 (50.0)11 (36.7)17 (51.5)11 (28.9)11 (40.7)11 (26.8)18 (72.0)7 (21.2)18 (56.3)
 Total29 (27.1)48 (56.5)11 (31.4)16 (50.0)11 (36.7)17 (51.5)11 (28.9)11 (40.7)11 (26.8)18 (72.0)7 (21.2)18 (56.3)
  • Abbreviations: InO, inotuzumab ozogamicin; MESF, molecules of equivalent soluble fluorochrome; SC, standard of care; TEAE, treatment-emergent adverse event.

  • aNo grade 5 neutropenia, thrombocytopenia, or febrile neutropenia occurred.