Integrated safety in tocilizumab clinical trials

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

	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
Any^a	278.2	441.1	340.4	284.7	245.5
Severe^{a, b}	18.0	24.0	20.7	17.3	15.3
Treatment related^{a, c}	112.8	214.7	141.0	106.4	85.2
Led to withdrawal^a	5.8	11.5	6.7	4.9	3.5
Led to dose modification/ interruption^a	36.6	41.3	40.2	37.3	37.8
SAEs, rate/100 PY
Any^a	14.4	15.9	15.1	13.9	14.0
Treatment related^c	5.0	6.0	5.1	4.0	4.9

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.

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