Table 3

Levels of D-dimer in controls and VTE cases using a cut-off of 2×ULN at baseline and month 12 (D-dimer data set)

Treatment armBaselineMonth 12
ULNControls,
n (%)
VTE cases,
n (%)
Controls,
n (%)
VTE cases,
n (%)
Tofacitinib 5 mg two times per day≥2×ULN
<2×ULN
618 (50)
625 (50)
9 (64)
5 (36)
282 (26)
798 (74)
6 (100)
0 (0)
Tofacitinib 10 mg two times per day*≥2×ULN
<2×ULN
602 (50)
592 (50)
21 (68)
10 (32)
290 (29)
717 (71)
11 (58)
8 (42)
TNFi≥2×ULN
<2×ULN
599 (48)
642 (52)
6 (67)
3 (33)
316 (30)
740 (70)
2 (40)
3 (60)
  • *For patients assigned to receive tofacitinib at a dose of 10 mg two times per day who had their dose reduced to 5 mg two times per day, the data collected after patients had been switched to 5 mg two times per day were counted in the arm receiving 10 mg two times per day.

  • TNFi, tumour necrosis factor inhibitor; ULN, upper limit of normal; VTE, venous thromboembolism.