Table 1 Summary of the safety assessment in each sub-group within the patients in special situations

Patients eligible for safety analysis

437

368

69

50

(11.4%)

16

(3.7%)

11

(2.5%)

71

(16.2%)

Patients who received GMA retreatment

131

109

22

13

(9.9%)

3

(2.3%)

3

(2.3%)

11

(8.4%)

Patients on multiple immunosuppressant medications

125

95

30

19

(15.2%)

5

(4.0%)

5

(4.0%)

23

(18.4%)

Elderly patients (≥ 65 years)

125

118

7

14

(11.2%)

7

(5.6%)

0

22

(17.6%)

Anaemic patients (haemoglobin < 10 g/dL)

105

89

16

19

(18.1%)

7

(6.7%)

4

(3.8%)

22

(21.0%)

Paediatric/adolescent patients (≤ 18 years)

53

40

13

10

(18.9%)

4

(7.5%)

3

(5.7%)

11

(20.8%)

Patients with diabetes mellitus

23

20

3

4

(17.4%)

1

(4.3%)

0

4

(17.4%)

Patients with ischaemic heart disease or arrhythmia

20

19

1

4

(20.0%)

2

(10.0%)

0

4

(20.0%)

Patients with viral hepatitis

19

18

1

3

(15.8%)

2

(10.5%)

0

6

(31.6%)

Patients with past or current malignancy

19

16

3

1

(5.3%)

0

0

3

(15.8%)

Patients with arrhythmia

16

14

2

2

(12.5%)

1

(6.3%)

0

1

(6.3%)

Patients with hypertension

16

16

0

2

(12.5%)

0

0

2

(12.5%)

Patients with liver disorder

15

14

1

5

(33.3%)

4

(26.7%)

0

1

(6.7%)

Patients with intestinal fistula

14

0

14

2

(14.3%)

0

1

(7.1%)

2

(14.3%)

Patients infected by cytomegalovirus

14

14

0

2

(14.3%)

1

(7.1%)

0

2

(14.3%)

Patients with renal disorder

13

11

2

1

(7.7%)

1

(7.7%)

0

1

(7.7%)

Pregnant or lactating mothers

12

12

0

0

0

0

1

(8.3%)

Patients with pyoderma gangrenous

9

7

2

0

0

0

1

(11.1%)

Patients with dyslipidemia

9

9

0

1

(11.1%)

0

0

0

Patients refractory or intolerant to biologics

8

5

3

0

0

0

1

(12.5%)

Patients with erythema nodosum

8

8

0

0

0

0

1

(12.5%)

Patients intolerant to 5-aminosalicylates

8

7

1

0

0

0

2

(25.0%)

Patients with CD receiving GMA monotherapy

8

0

8

1

(12.5%)

1

(12.5%)

0

2

(25.0%)

Patients with psychiatric disorders

6

6

0

0

0

0

3

(50.0%)

Patients with primary sclerosing cholangitis

4

4

0

0

0

0

0

Patients allergic to anticoagulants

4

4

0

3

(75.0%)

0

2

(50.0%)

3

(75.0%)

Patients with intestinal stenosis

3

0

3

1

(33.3%)

0

1

(33.3%)

1

(33.3%)

Others

12

11

1

3

(13.6%)

1

(8.3%)

1

(8.3%)

4

(18.2%)