Table 2.

Proportions of patients with AEs, serious AEs and most frequently reported AEs,^a by cohort

	Induction Cohort [8 weeks]b		Maintenance Cohort [52 weeks]b			Overall [Dec 2016] Cohort [≤4.4 years]b,c	Overall plus P3b/4 [2020] Cohort [≤7.8 years]d
	Placebo [N = 282]	Tofacitinib 10 mg BID [N = 938]	Placebo [N = 198]	Tofacitinib 5 mg BID [N = 198]	Tofacitinib 10 mg BID [N = 196]	Tofacitinib All [N = 1157]	PD tofacitinib 5 mg BID [N = 202]	PD tofacitinib 10 mg BID [N = 955]	Tofacitinib All [N = 1157]
AEs
Patients with AEs, n [%]	155 [55.0]	515 [54.9]	149 [75.3]	143 [72.2]	156 [79.6]	950 [82.1]	189 [93.6]	803 [84.1]	992 [85.7]
Patients with serious AEs, n [%]	18 [6.4]	36 [3.8]	13 [6.6]	10 [5.1]	11 [5.6]	169 [14.6]	44 [21.8]	200 [20.9]	244 [21.1]
Discontinuations due to AEs, n [%]	14 [5.0]	36 [3.8]	37 [18.7]	18 [9.1]	19 [9.7]	75 [7.9]	24 [11.9]	110 [11.5]	134 [11.6]
Most frequently reported AEs, n [%]a
Worsening UC	20 [7.1]	26 [2.8]	71 [35.9]	36 [18.2]	29 [14.8]	224 [19.4]	49 [24.3]	258 [27.0]	307 [26.5]
Nasopharyngitis	14 [5.0]	56 [6.0]	11 [5.6]	19 [9.6]	27 [13.8]	211 [18.2]	59 [29.2]	196 [20.5]	255 [22.0]
Arthralgia	12 [4.3]	27 [2.9]	19 [9.6]	17 [8.6]	17 [8.7]	122 [10.5]	32 [15.8]	117 [12.3]	149 [12.9]
Headache	19 [6.7]	73 [7.8]	12 [6.1]	17 [8.6]	6 [3.1]	121 [10.5]	34 [16.8]	114 [11.9]	148 [12.8]
Blood creatine phosphokinase increased	3 [1.1]	25 [2.7]	4 [2.0]	6 [3.0]	13 [6.6]	115 [9.9]	30 [14.9]	108 [11.3]	138 [11.9]
Upper respiratory tract infection	6 [2.1]	26 [2.8]	7 [3.5]	13 [6.6]	12 [6.1]	103 [8.9]	24 [11.9]	113 [11.8]	137 [11.8]
Influenza	3 [1.1]	9 [1.0]	7 [3.5]	4 [2.0]	7 [3.6]	67 [5.8]	21 [10.4]	84 [8.8]	105 [9.1]
Hypertension	1 [0.4]	9 [1.0]	1 [0.5]	4 [2.0]	4 [2.0]	33 [2.9]	26 [12.9]	41 [4.3]	67 [5.8]

For the Induction and Maintenance Cohorts, 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] Cohorts, all events, including those outside the 28-day risk period, were included.

^aData are reported for all AEs by preferred term, which occurred in ≥10% of patients in a treatment group in the Overall plus P3b/4 [2020] Cohort.

^bData for the Induction, Maintenance and Overall [Dec 2016] Cohorts were previously reported by Sandborn et al.⁷

^cThe previously reported Overall [Dec 2016] Cohort included data from OCTAVE Open up to December 2016 [≤4.4 years of exposure].

^dThe 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; N, number of patients treated in the treatment group; n, number of unique patients in the specified category; PD, predominant dose; UC, ulcerative colitis.