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

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


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.

Schiff et al. Arthritis Research & Therapy 2011 13:R141   doi:10.1186/ar3455

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