Table 3.

Safety summary through weeks 12 and 24

	Weeks 0–12 Baricitinib					Weeks 12–24 Baricitinib		Weeks 0–24 Baricitinib
	Placebo once daily (N=98)	1 mg once daily (N=49)	2 mg once daily (N=52)	4 mg once daily (N=52)	8 mg once daily (N=50)	Combined 2 mg twice daily*† (N=61)	Combined 4 mg once daily*† (N=61)	2 mg once daily (N=52)	4 mg once daily (N=52)	8 mg once daily (N=50)
TEAE, n (%)	45 (46)	20 (41)	24 (46)	22 (42)	26 (52)	29 (48)	27 (44)	31 (60)	32 (62)	36 (72)
SAE, n (%)	3 (3)	0	3 (6)	0	1 (2)	3 (5)‡	1 (2)‡	3 (6)	0	4 (8)
Serious infection, n (%)	0	0	2 (4)	0	0	0	0	2 (4)	0	1 (2)
Discontinuations due to AEs, n (%)	5 (5)	1 (2)	1 (2)	1 (2)	1 (2)	1 (2)	0	1 (2)	2 (4)	1 (2)

*Patients originally assigned to placebo or baricitinib 1 mg once daily at study entry and re-randomised to receive baricitinib 2 mg twice daily or 4 mg once daily for an additional 12 weeks.

†Data for baricitinib combined 2 mg twice daily or combined 4 mg once daily are reported for weeks 12–24.

‡One SAE in each of the baricitinib combined 2 mg twice daily (hyperglycaemia) or combined 4 mg once daily (haematuria) groups began prior to week 12 and continued into weeks 12–24.

AE, adverse event; N, number of patients randomised and treated; n, number of patients with event; SAE, serious adverse event; TEAE, treatment-emergent adverse event.