Table 3.

Treatment-emergent infections [all-causality] in the Overall Cohort.

Adverse event, n [%]	Tofacitinib all doses [N = 1157]	PD tofacitinib 5 mg BID [N = 198]	PD tofacitinib 10 mg BID [N = 959]
Infections [all]	641 [55.4]	132 [66.7]	509 [53.1]
Dose reduction or temporary discontinuations due to infections	49 [4.2]	10 [5.1]	39 [4.1]
Deaths due to infections	0 [0.0]	0 [0.0]	0 [0.0]
Infections occurring in ≥2% of patients in any treatment group
Nasopharyngitis	251 [21.7]	56 [28.3]	195 [20.3]
Upper respiratory tract infection	128 [11.1]	21 [10.6]	107 [11.2]
Influenza	99 [8.6]	18 [9.1]	81 [8.4]
Herpes zoster [non-serious and serious]	80 [6.9]	20 [10.1]	60 [6.3]
Gastroenteritis	76 [6.6]	9 [4.5]	67 [7.0]
Bronchitis	58 [5.0]	19 [9.6]	39 [4.1]
Urinary tract infection	57 [4.9]	17 [8.6]	40 [4.2]
Sinusitis	42 [3.6]	11 [5.6]	31 [3.2]
Pharyngitis	39 [3.4]	12 [6.1]	27 [2.8]
Folliculitis	29 [2.5]	6 [3.0]	23 [2.4]
Oral herpes	29 [2.5]	4 [2.0]	25 [2.6]

Patients are only counted once per treatment for each row. PD groups [the average daily tofacitinib dose levels in the entire UC clinical programme] were based on the average total daily dose of tofacitinib during tofacitinib treatment: PD 5 mg BID, an average total daily dose <15 mg; PD 10 mg BID, an average total daily dose ≥15 mg.

BID, twice daily; N, total number of patients in the treatment group; n, number of patients with events; PD, predominant dose; UC, ulcerative colitis.