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Table 6 Number of subjects (incidence rates) with specified abnormalities in haematology and biochemistry parameters during any time of the post-treatment follow-up period

From: Safety and tolerability of canakinumab, an IL-1β inhibitor, in type 2 diabetes mellitus patients: a pooled analysis of three randomised double-blind studies

 

Canakinumab pooled dose

Placebo

Low dose

Intermediate dose

Medium dose

High dose

I. Haematology parameters

WBC (total) (109/L), N

20

245

262

136

342

  Any grade 1–4 abnormality, n

0

19

18

10

14

  IR (%)

0.0

2.14

3.22

1.86

1.25

  Dose trend test, P value

  

0.0884

  

  G1 (<LLN–3.0), n (%)

0

18 (7.3)

15 (5.7)

10 (7.4)

13 (3.8)

  IR (%)

0.0

2.03

2.68

1.86

1.16

  G2 (<3.0–2.0), n (%)

0

1 (0.4)

4 (1.5)

1 (0.7)

1 (0.3)

  IR (%)

0.0

0.11

0.68

0.18

0.09

Absolute neutrophil counts (Seg. + bands) (109/L), N

20

222

258

93

288

  Any grade 1–4 abnormality, n

1

21

27

13

10

  IR (%)

0.89

2.68

4.95

4.61

1.22

  Dose trend test, P value

  

0.0001

  

  G1 (<LLN–1.5), n (%)

0

17 (7.7)

23 (8.9)

13 (14.0)

7 (2.4)

  IR (%)

0.0

2.13

4.17

4.59

0.85

  G2 (<1.5–1.0), n (%)

1 (5.0)

6 (2.7)

7 (2.7)

2 (2.2)

2 (0.7)

  IR (%)

0.89

0.74

1.26

0.66

0.24

Platelet counts (direct) (109/L), N

20

245

260

136

342

  Any grade 1–4 abnormality, n

1

11

9

4

11

  IR (%)

0.92

1.23

1.57

0.73

1.00

  Dose trend test, P value

  

0.9488

  

  G1 (<LLN–75), n (%)

1 (5.0)

10 (4.1)

9 (3.5)

4 (2.9)

11 (3.2)

  IR (%)

0.92

1.11

1.57

0.73

1.00

  G2 (<75–50), n (%)

0

0

0

1 (0.7)

0

  IR (%)

0.0

0.0

0.0

0.18

0.0

Absolute lymphocyte counts (109/L), N

20

222

258

93

288

  Any grade 1–4 abnormality, n

0

2

3

1

7

  IR (%)

0.0

0.25

0.53

0.33

0.85

  Dose trend test, P value

  

0.2241

  

  G1 (<LLN–0.8), n (%)

0

0

1 (0.4)

0

3 (1.0)

  IR (%)

0.0

0.0

0.18

0.0

0.36

  G2 (<0.8–0.5), n (%)

0

2 (0.9)

2 (0.8)

1 (1.1)

4 (1.4)

  IR (%)

0.0

0.25

0.36

0.33

0.48

Haemoglobin (g/L), N

20

245

262

136

342

  Any grade 1–4 abnormality, n

8

49

36

31

76

  IR (%)

9.20

6.27

6.83

6.68

7.97

  Dose trend test, P value

  

0.1239

  

  G1 (<LLN–100), n (%)

8 (40.0)

49 (20.0)

33 (12.6)

30 (22.1)

73 (21.3)

  IR (%)

9.09

6.23

6.24

6.41

7.63

  G2 (<100–80), n (%)

1 (5.0)

5 (2.0)

3 (1.1)

2 (1.5)

5 (1.5)

  IR (%)

0.90

0.54

0.51

0.36

0.44

II. Biochemistry parameters

SGPT (ALT) (U/L), N

20

245

262

136

343

  Any grade 1–4 abnormality, n

0

2

4

5

2

  IR (%)

0.0

0.21

0.69

0.88

0.17

  Dose trend test, P value

  

0.0158

  

  G1 (>3–5×ULN), n (%)

0

2 (0.8)

4 (1.5)

5 (3.7)

2 (0.6)

  IR (%)

0.0

0.21

0.69

0.88

0.17

SGOT (AST) (U/L), N

20

245

256

136

342

  Any grade 1–4 abnormality, n

0

1

0

2

0

  IR (%)

0.0

0.11

0.0

0.35

0.0

  Dose trend test, P value

  

0.0777

  

  G1 (>3–5×ULN), n (%)

0

1 (0.4)

0

2 (1.5)

0

  IR (%)

0.0

0.11

0.0

0.35

0.0

Bilirubin (total) (μmol/L), N

20

245

265

136

344

  Any grade 1–4 abnormality, n

0

0

3

4

6

  IR (%)

0.0

0.0

0.52

0.70

0.52

  Dose trend test, P value

  

0.6430

  

  G1 (>1.5–2×ULN), n (%)

0

0

2 (0.8)

3 (2.2)

5 (1.5)

  IR (%)

0.0

0.0

0.34

0.52

0.44

  G2 (>2–3×ULN), n (%)

0

0

2 (0.8)

2 (1.5)

0

  IR (%)

0.0

0.0

0.34

0.35

0.0

Alkaline phosphatase, serum (U/L), N

20

245

263

136

344

  Any grade 1–4 abnormality, n

0

0

0

0

1

  IR (%)

0.0

0.0

0.0

0.0

0.09

  Dose trend test, P value

  

0.2357

  

  G1 (>2–3×ULN), n (%)

0

0

0

0

1 (0.3)

  IR (%)

0.0

0.0

0.0

0.0

0.09

  G2 (>3–5×ULN), n (%)

0

0

0

0

1 (0.3)

  IR (%)

0.0

0.0

0.0

0.0

0.09

Creatinine (umol/L), N

20

245

265

136

344

  Any grade 1–4 abnormality, n

1

10

11

6

10

  IR (%)

0.91

1.06

1.89

1.06

0.88

  Dose trend test, P value

  

0.3490

  

  G1 (>ULN–1.5×ULN), n (%)

1 (5.0)

10 (4.1)

11 (4.2)

6 (4.4)

10 (2.9)

  IR (%)

0.91

1.06

1.88

1.06

0.88

  G2 (>1.5–3×ULN), n (%)

0

1 (0.4)

1 (0.4)

0

0

  IR (%)

0.0

0.11

0.17

0.0

0.0

  1. Abnormalities are presented as number (n) and/or % of patients. Incidence rate (IR) is expressed as % per visit. Subjects are counted only once if specified abnormality occurred multiple times during the treatment or post-treatment follow-up period. Subjects can be counted more than once in multiple categories and grades. The Jonckheere-Terpstra test was used to test for a monotonic trend across doses in the proportion of post-baseline visits with any laboratory abnormality among the total number of post-baseline visits.
  2. CTC, common terminology criteria; G, grade; WBC, white blood cell; SGOT, serum glutamic oxaloacetic transaminase; SGPT, serum glutamic pyruvic transaminase.
  3. Low dose: 0.03 mg/kg i.v. once; intermediate dose: 0.1 and 0.3 mg/kg i.v. once, 5 and 15 mg s.c. monthly; medium dose: 1.5 mg/kg i.v. once, 50 mg s.c. monthly and 150 mg s.c. once; high dose: 10 mg/kg i.v. once and 150 mg s.c. monthly.
  4. Total WBC count: Normal range = 4.5–11.0 × 109/L; Absolute neutrophil counts: Normal range = 1.5–8.0 × 109/L; Haemoglobin: Normal range = 13.5–17.5% (males) and 12.0–16.0% (females); Platelet count (direct): Normal range = 150–450 × 109/L; Absolute lymphocyte count: Normal range = 1.0–4.0 × 109/L; SGOT (AST): Normal range = 3–44 U/L; SGPT (ALT): Normal range = 0–40 U/L; Bilirubin (total): Normal range = 5–17.0 μmol/L; Alkaline phosphatase, serum: Normal range = 30–125 U/L; Creatinine: Normal range = 45–90 μmol/L (females) and 60–110 μmol/L (males).