Table 3 Safety assessment: adverse event (AE) reports

AE

2053/34.3 (32.8–35.8)

1345/35.6 (33.7–37.5)

1.0 (0.9–1.03)

0.3

SAE

226/3.8 (3.3–4.3)

52/1.4 (1.1–1.8)

2.8 (2.0–3.7)

0.0001*

Serious infection

54/0.9 (0.7–1.2)

8/0.2 (0.1–0.4)

4.3 (2.0–9.0)

0.0001*

Herpes zoster

24/0.4 (0.3–0.6)

4/0.1 (0.04–0.3)

3.8 (1.3–10.9)

0.01*

Neutropenia

4/0.07 (0.03–0.18)

2/0.05 (0.01–0.2)

1.3 (0.2–6.9)

0.8

MAS

2/0.03 (0.008–0.3)

1/0.03 (0.004–0.19)

1.3 (0.1–13.9)

0.9

High transaminases

97/1.6 (1.3–2.0)

175/4.6 (4.0–5.4)

0.4 (0.3–0.5)

0.0001*

IBD

19/0.3 (0.2–0.5)

1/0.03 (0.004–0.19)

12.0 (1.6–89.7)

0.015*

Uveitis

113/1.9 (1.6–2.3)

54/1.4 (1.1–1.9)

1.3 (0.96–1.8)

0.09

Psoriasis

4/0.07 (0.03–0.18)

1/0.03 (0.004–0.19)

2.5 (0.3–22.6)

0.4

Demyelination

1/0.02 (0.002–0.1)

0/n.a.

n.a.

n.a.

Depression

15/0.25 (0.2–0.4)

2/0.05 (0.01–0.2)

4.7 (1.1–20.7)

0.04*

Malignancy

3/0.05 (0.02–0.2)

2/0.05 (0.01–0.2)

1.0 (0.2–5.7)

0.95

Death

3/0.05 (0.02–0.2)

1/ 0.03 (0.004–0.19)

1.9 (0.2–18.2)

0.6