Table 2.

AE overview

	Weeks 0–24*			Weeks 0–48
	Placebo (n=228)	Baricitinib 2 mg QD (n=229)	Baricitinib 4 mg QD (n=227)	Baricitinib 2 mg QD (n=229)	Baricitinib 4 mg QD (n=227)
SAEs†	11 (5)	6 (3)	12 (5)	12 (5)	24 (11)
Serious infections‡	4 (2)	2 (<1)	4 (2)	3 (1)	6 (3)
Deaths	2 (<1)	0	0	0	1 (<1)
AEs → permanent study drug discontinuation	11 (5)	12 (5)	14 (6)	18 (8)	19 (8)
TEAEs	161 (71)	154 (67)	162 (71)	172 (75)	186 (82)
Infections	79 (35)	70 (31)	96 (42)	88 (38)	119 (52)
Herpes zoster	0	4 (2)	3 (1)	8 (3)	5 (2)
TB	0	0	1 (<1)	0	1 (<1)
Malignancy‡	0	0	1 (<1)	1 (<1)	1 (<1)
MACE‡§	2 (<1)	0	0	0	0

*The data for Weeks 0–24 have been replicated from Dougados et al.⁸ It has been reproduced in the table to provide context. Values include events that occurred during the study treatment period.

†SAEs are reported on the basis of conventional International Conference on Harmonisation definitions and not on the basis of the study protocol. (The protocol required that AEs or laboratory abnormalities leading to permanent discontinuation of study drug be designated as SAEs.) The data shown are numbers and percentages of patients with SAEs, up to the time of rescue.

‡Week 0–48 values for serious infections, malignancy, and MACE include the follow-up period.

§MACE was defined as cardiovascular death, myocardial infarction or stroke positively adjudicated by an independent cardiovascular evaluation committee.

AE, adverse event; MACE, QD, once daily; SAE, serious adverse events; TEAEs, treatment-emergent adverse events.