Table 2

Adverse events by group

Double-blind phaseCumulative data*
Placebo
(n=14)
Tocilizumab
(n=13)
Tocilizumab
(n=27)
Number of adverse events1238182
 Number of patients8 (57.1)11 (84.6)27 (100.0)
Most frequently reported events†
 Nasopharyngitis0 (0.0)3 (23.1)11 (40.7)
 Constipation0 (0.0)2 (15.4)4 (14.8)
 Anaemia0 (0.0)0 (0.0)4 (14.8)
 Insomnia1 (7.1)0 (0.0)4 (14.8)
 Dyslipidaemia1 (7.1)1 (7.7)5 (18.5)
 Drug eruption0 (0.0)0 (0.0)4 (14.8)
Number of serious adverse events0011‡
 Subcutaneous abscess0 (0.0)0 (0.0)1 (3.7)
 Cellulitis0 (0.0)0 (0.0)2 (7.4)
 Spleen abscess0 (0.0)0 (0.0)1 (3.7)
 Pneumonia0 (0.0)0 (0.0)1 (3.7)
 Adult-onset Still’s disease exacerbation0 (0.0)0 (0.0)1 (3.7)
 Anaphylaxis shock0 (0.0)0 (0.0)2 (7.4)§
 Drug eruption0 (0.0)0 (0.0)1 (3.7)
 Aseptic necrosis0 (0.0)0 (0.0)1 (3.7)
 Malignant lymphoma0 (0.0)0 (0.0)1 (3.7)¶
 Macrophage activation syndrome0 (0.0)0 (0.0)0 (0.0)
 Death0 (0.0)0 (0.0)0 (0.0)
Infusion reaction1 (7.1)3 (23.1)5 (18.5)
Antitocilizumab antibody1 (7.7)2 (7.4)
  • Multiple occurrences in one patient were counted. Data are n (%) unless otherwise stated.

  • *Cumulative data included safety profile for all patients while receiving tocilizumab.

  • †Only adverse events that occurred in three or more participants in either group in the double-blind phase or in four or more participants in all participants while receiving tocilizumab are presented.

  • ‡11 serious adverse events in seven patients were observed.

  • §One was attributed to tocilizumab and one to contrast enhancement during a CT.

  • ¶The underlying disease of the participant in the placebo group was found to be malignant lymphoma, rather than adult-onset Still’s disease.