Figure 2.

Incidence of [A] malignancies [excluding NMSC],^a,b,c [B] NMSC,^a,b,c [C] MACE,^a,b,c [D] DVT,^d,e [E] PE^d,e and [F] GI perforations,^b,c,d,f by cohort.

^aFor the Maintenance Cohort, events that occurred >28 days after the last dose of the study drug were excluded; for the Overall [Dec 2016] and Overall plus P3b/4 [2020] Cohort, all events, including those outside the 28-day risk period, were included.

^bAdjudicated events.

^cFor the Overall plus P3b/4 [2020] Cohort, N = 922 and N = 1124 for the PD tofacitinib 10 mg BID and tofacitinib all groups, respectively [excludes phase 2 study data, as the phase 2 induction study took place prior to the establishment of the adjudication committees].

^dEvents that occurred >28 days after the last dose of the study drug were excluded.

^eVTEs included adjudicated events from OCTAVE Open and RIVETING plus selected events from phase 2/3 studies from the Narrow Standardized MedDRA query for embolic and thrombotic events.

^fGI perforation excludes preferred terms of pilonidal cyst, perirectal abscess, rectal abscess, anal abscess, perineal abscess and any preferred terms containing the term fistula.

^gIncludes data previously reported by Sandborn et al.⁷; the previously reported Overall [Dec 2016] Cohort included data from OCTAVE Open up to December 2016 [≤4.4 years of exposure].

^hThe Overall plus P3b/4 [2020] Cohort includes final data from OCTAVE Open [final data cut-off: August 24, 2020], and data from RIVETING [interim data cut-off: February 20, 2020; ≤7.8 years of exposure].

AE, adverse event; BID, twice daily; CI, confidence interval; DVT, deep vein thrombosis; GI, gastrointestinal; IR, incidence rate [unique patients with events/100 PY of exposure]; MACE, major adverse cardiovascular events; N, number of patients treated in the treatment group; n, number of unique patients with a particular AE; MedDRA, Medical Dictionary for Regulatory Activities; NMSC, non-melanoma skin cancer; PD, predominant dose; PE, pulmonary embolism; PY, patient-years; VTE, venous thromboembolic event.