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Table 2 Serious adverse events recorded by previous studies after TCZ infusion in sJIA patients

From: Severe sepsis caused by serious gastrointestinal infection in sJIA patients treated with IL-6 receptor antagonist: a case report

Authors and referencesYearsStudy designDurationNo. of patientsSAEs
no. of events
Serious infections
no. of events
Serious GI infections
no. of events
sepsis
no. of events
Yokota et al. [6]2005OL, Phase II14 weeks110000
Woo et al. [7]2005OL, Phase II4–8 weeks155200
Yokota et al. [8]2008R, DB, PC, Phase III6 weeks OL lead-in phase
12 weeks DB phase
48 weeks OL- extension phase
5615UnknownbUnknownb0
De Benedetti et al. [2]2012R, DB, PC, Phase III12 weeks DB phase
96 weeks OL extension phase
112391851
Yokota et al. [9]2014Long-term extension study of their 2 previous studies168 weeks677830130
Yokota et al. [10]2016Post marketing surveillance52 weeks4172227493
Horneff et al. [11]2017Retrospective study2000–201571a14200
Kimura et al. [12]2017Pilot study9 months10a1000
Bielak et al. [13]2018Retrospective study7/2009–4/2014462000
  1. OL open-label, R randomized, DB double blind, PC placebo-controlled, SAEs serious adverse events, GI gastrointestinal
  2. anumber of patients involved in the sJIA group of the study
  3. bthe article did not clearly list the number of serious infection or serious GI infection, but only indicated that 2 cases of serious GI infections resolved with antibiotic treatment