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.

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