Table 4

Summary of all adverse events over the safety reporting period—safety population (N=603)

n (%)MONO group
N=234
COMBO group
N=369
All patients
N=603
Adverse events (AEs)
Patients with ≥1 AE128 (54.7)197 (53.4)325 (53.9)
Number of AEs420566986
Patients with ≥1 AE related* to tocilizumab93 (39.7)129 (35.0)222 (36.8)
Number of AEs related* to tocilizumab203261464
Patients with ≥1 AE leading to tocilizumab permanent discontinuation25 (10.7)35 (9.5)60 (10.0)
Number of AEs leading to tocilizumab permanent discontinuation354681
Patients with ≥1 AE leading to death2 (0.9)1 (0.3)3 (0.5)
Number of AEs leading to death314
Patients with ≥1 AE related* to tocilizumab leading to death1 (0.4)01 (0.2)
Number of AEs related* to tocilizumab leading to death101
Serious adverse events (SAEs)
Patients with ≥1 SAE31 (13.2)43 (11.7)74 (12.3)
Number of SAEs5159110
Patients with ≥1 SAE related* to tocilizumab12 (5.1)18 (4.9)30 (5.0)
Number of SAEs related* to tocilizumab202242
Adverse events of special interest (AESIs)†
Patients with ≥1 AESI47 (20.1)73 (19.8)120 (19.9)
Number of AESIs7599174
Patients with ≥1 AESI related* to tocilizumab29 (12.4)42 (11.4)71 (11.8)
Number of AESIs related* to tocilizumab435194
Patients with ≥1 AESI leading to tocilizumab permanent discontinuation16 (6.8)20 (5.4)36 (6.0)
Number of AESIs leading to tocilizumab permanent discontinuation202242
Serious adverse events of special interest (SAESIs)
Patients with ≥1 SAESI19 (8.1)30 (8.1)49 (8.1)
Number of SAESIs263460
Patients with ≥1 SAESI related* to tocilizumab9 (3.8)17 (4.6)26 (4.3)
Number of SAESIs related* to tocilizumab161834
  • *In case of missing information about causal relationship with tocilizumab, the AE was considered as related to treatment.

  • †AESIs: anaphylaxis/hypersensitivity reactions, demyelinating disorders, gastrointestinal perforations, malignancies, myocardial infarctions/acute coronary syndromes, serious and/or medically significant infections, serious and/or medically significant hepatic events, serious and/or medically significant bleeding events and strokes.

  • csDMARD, conventional synthetic disease-modifying antirheumatic drug; COMBO, tocilizumab in combination with csDMARD at inclusion; MONO, tocilizumab as monotherapy at inclusion.