Table 2 Treatment-emergent adverse events and hematologic laboratory abnormalities.

From: Inotuzumab ozogamicin for relapsed/refractory acute lymphoblastic leukemia: outcomes by disease burden

Event, n (%)

BMB < 50%

BMB 50–90%

BMB > 90%

 

InO (n = 53)

SC (n = 43)

InO (n = 79)

SC (n = 71)

InO (n = 30)

SC (n = 28)

TEAEs (grade ≥ 3)a

 Any TEAE

47 (88.7)

42 (97.7)

71 (89.9)

69 (97.2)

29 (96.7)

26 (92.9)

 Blood and lymphatic system disorders

41 (77.4)

38 (88.4)

62 (78.5)

63 (88.7)

26 (86.7)

22 (78.6)

 Thrombocytopenia

21 (39.6)

29 (67.4)

36 (45.6)

42 (59.2)

10 (33.3)

14 (50.0)

 Neutropenia

23 (43.4)

18 (41.9)

44 (55.7)

36 (50.7)

9 (30.0)

8 (28.6)

 Anemia

10 (18.9)

22 (51.2)

18 (22.8)

29 (40.8)

8 (26.7)

11 (39.3)

 Leukopenia

9 (17.0)

19 (44.2)

24 (30.4)

28 (39.4)

11 (36.7)

6 (21.4)

 Lymphopenia

9 (17.0)

15 (34.9)

12 (15.2)

17 (23.9)

5 (16.7)

4 (14.3)

 Febrile neutropenia

9 (17.0)

24 (55.8)

17 (21.5)

39 (54.9)

16 (53.3)

13 (46.4)

 Hepatobiliary disorders

11 (20.8)

3 (7.0)

13 (16.5)

6 (8.5)

4 (13.3)

3 (10.7)

 VOD/SOSb

7 (13.2)

1 (2.3)

10 (12.7)

2 (2.8)

2 (6.7)

0

 Hyperbilirubinemia

4 (7.5)

2 (4.7)

3 (3.8)

4 (5.6)

3 (10.0)

3 (10.7)

 Infections and infestations

18 (34.0)

25 (58.1)

18 (22.8)

38 (53.5)

12 (40.0)

15 (53.6)

 Bacteremia

2 (3.8)

4 (9.3)

1 (1.3)

5 (7.0)

3 (10.0)

1 (3.6)

 Neutropenic sepsis

0

1 (2.3)

2 (2.5)

3 (4.2)

3 (10.0)

2 (7.1)

 Klebsiella bacteremia

1 (1.9)

1 (2.3)

0

1 (1.4)

0

3 (10.7)

 Sepsis

1 (1.9)

3 (7.0)

3 (3.8)

6 (8.5)

1 (3.3)

3 (10.7)

 Investigations

18 (34.0)

10 (23.3)

23 (29.1)

14 (19.7)

8 (26.7)

9 (32.1)

 GGT increased

8 (15.1)

4 (9.3)

8 (10.1)

2 (2.8)

2 (6.7)

1 (3.6)

 AST increased

2 (3.8)

1 (2.3)

2 (2.5)

2 (2.8)

3 (10.0)

2 (7.1)

 ALT increased

1 (1.9)

1 (2.3)

3 (3.8)

3 (4.2)

2 (6.7)

3 (10.7)

 Metabolism and nutrition disorders

9 (17.0)

8 (18.6)

12 (15.2)

16 (22.5)

6 (20.0)

7 (25.0)

 Hypokalemia

4 (7.5)

2 (4.7)

6 (7.6)

10 (14.1)

1 (3.3)

1 (3.6)

 Hypocalcemia

0

0

2 (2.5)

1 (1.4)

1 (3.3)

4 (14.3)

Hematologic laboratory abnormalities (grade ≥ 3)

 Activated partial thromboplastin time prolonged

0

1 (2.3)

2 (2.5)

2 (2.8)

3 (10.0)

0

 Hemoglobin decreased

17 (32.1)

27 (62.8)

27 (34.2)

54 (76.1)

23 (76.7)

20 (71.4)

 INR increased

0

0

1 (1.3)

1 (1.4)

0

0

 Leukocytes decreased

36 (67.9)

42 (97.7)

66 (83.5)

70 (98.6)

29 (96.7)

27 (96.4)

 Lymphopenia

32 (60.4)

38 (88.4)

56 (70.9)

58 (81.7)

26 (86.7)

21 (75.0)

 Neutrophil count decreased

38 (71.7)

36 (83.7)

71 (89.9)

56 (78.9)

29 (96.7)

22 (78.6)

 Platelet count decreased

34 (64.2)

42 (97.7)

60 (75.9)

71 (100.0)

29 (96.7)

27 (96.4)

 Prothrombin time increased

0

1 (2.3)

0

0

0

0

  1. Data represent the safety population.
  2. TEAEs and hematologic laboratory abnormalities were graded according to the NCI CTCAE, version 3.0.
  3. ALT alanine aminotransferase, AST aspartate aminotransferase, BMB bone marrow blast, GGT gamma-glutamyl transferase, InO inotuzumab ozogamacin, INR international normalized ratio, NCI CTCAE National Cancer Institute Common Terminology Criteria for Adverse Events, SC standard of care chemotherapy, TEAE treatment-emergent adverse event, VOD/SOS veno-occlusive disease/sinusoidal obstruction syndrome.
  4. aAll-causality TEAEs grade ≥3 with ≥10% incidence occurring in either arm (any treatment cycle, any BMB subgroup) are shown.
  5. bIn July 2017 (after the clinical database was locked), a fourth case of VOD/SOS was confirmed to have occurred in an SC arm patient. This case of VOD/SOS occurred in March 2013, was not entered on the clinical report form, and is therefore not included.
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