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Table 2 Rates of adverse events by duration of observation in the all-exposed population

From: Integrated safety in tocilizumab clinical trials

  All-exposed population
n= 4,009
  Overall ≤ 6
months
7-12 months 13-18 months > 18 months
Total duration, PY 9,414 1,805 1,664 1,542 4,404
AEs, rate/100 PY
   Anya 278.2 441.1 340.4 284.7 245.5
   Severea, b 18.0 24.0 20.7 17.3 15.3
   Treatment relateda, c 112.8 214.7 141.0 106.4 85.2
   Led to withdrawala 5.8 11.5 6.7 4.9 3.5
Led to dose modification/
interruptiona
36.6 41.3 40.2 37.3 37.8
SAEs, rate/100 PY
   Anya 14.4 15.9 15.1 13.9 14.0
   Treatment relatedc 5.0 6.0 5.1 4.0 4.9
  1. AE, adverse event; PY, patient-years; SAE, serious AE. aMultiple occurrences of the same AE in one individual are counted once in each period. bIntensity of AEs graded by the investigator as mild, moderate, or severe. cRelated AEs are those considered by the investigator to be remotely, possibly, or probably related to study drug.