Table 3 Safety

Patients, n

236; 236.4

419

74

Patient years, n

236.4

524,096

72,47364819

Exposure, years mean ± SD

1.00 ± 0.86

1.25 ± 1.05

0.98 ± 0.60

Adverse events, n; n/patient

386; 1.63

996; 2.37

102: 1.38

p = 0.011

p = 0.004

Rate/100 PY (95% CI)

163.3 (148.8; 180.4)

190.0 (178.6; 202.2)

140,7 (113.5; 167.4)

RR 1.16 (1.03–1.31)

ns

RR 1.35 (1.1–1.66)

Serious adverse events, n; n/patient

26; 0.11

119; 0.28

3; 0.04

p = 0.0008

p = 0.004

Rate/100 PY (95% CI)

11.0 (7.5; 16.2)

22.07 (19.0; 27.2)

4.1 (1.3; 12.8)

RR 2.06 (1.35–3.16)

ns

RR 5.48 (1.74–17.25)

Autoimmunopathy, n; n/patient

3; 0.012

2; 0.004

1; 0.014

Rate/100 PY (95% CI)

1.27 (0.41; 3.39)

0.38 (0.09; 1.53)

1.38 (0.19; 9.59)

ns

ns

ns

Bleeding disorder, n; n/patient

2; 0.008

3; 0.007

0

Rate/100 PY (95% CI)

0.85 (0.21; 3.38)

0.57 (0.18; 1.17)

ns

ns

ns

CED, n; n/patient

1; 0.004

13; 0.031

0

p = 0.09

Rate/100 PY (95% CI)

0.42 (0.06; 3.0)

2.48 (1.44; 4.27)

RR 5.86 (0.77–44.83)

ns

ns

Demyelinisation

0

1; 0.002

0

Rate/100 PY (95% CI)

0.19 (0.03-1.35)

ns

ns

ns

Hepatitis

6; 0.025

10; 0.024

3; 0.041

Rate/100 PY (95% CI)

2.54 (1.14; 5.65)

1.91 (1.03; 3.55)

4.14 (1.31; 12.57)

ns

ns

ns

Hyperlipidemia

0

3; 0.007

1; 0.014

Rate/100 PY (95% CI)

0.57 (0.18; 1.17)

1.38 (0.19; 9.59)

ns

ns

ns

Infection. serious or medically important; n; n/patient

13; 0.055

50; 0.119

3; 0.041

p = 0.076

Rate/100 PY (95% CI)

5.5 (3.19; 9.47)

9.54 (7.23; 12.59)

4.14 (1.31; 12.57)

RR 1.73 (0.94–3.19)

ns

ns

Intolerance, n; n/patient

2; 0.008

3; 0.007

2; 0.027

Rate/100 PY (95% CI)

0.85 (0.21; 3.38)

0.57 (0.18; 1.17)

2.76 (0.68; 10.81)

ns

ns

ns

Malignancy, n; n/patient

0

1; 0.002

0

Rate/100 PY (95% CI)

0.19 (0.03; 1.35)

ns

ns

ns