Table 3.

Adverse events in the safety population by day 28

		Baricitinib plus standard of care group (n=50)	Placebo plus standard of care group (n=49)
Treatment-emergent adverse event*		44 (88%)	47 (96%)
	Mild	3 (6%)	3 (6%)
	Moderate	17 (34%)	11 (22%)
	Severe	24 (48%)	33 (67%)
Death due to adverse event†		5 (10%)	3 (6%)
Serious adverse event		25 (50%)	35 (71%)
Discontinuation from study treatment due to adverse event (including death)		14 (28%)	17 (35%)
Treatment-emergent infection		35 (70%)	35 (71%)
	Serious infections	22 (44%)	26 (53%)
	Herpes simplex virus	1 (2%)	0
	Opportunistic infections‡	0	2 (4%)
Venous thromboembolic event§		3 (6%)	3 (6%)
	Deep vein thrombosis	1 (2%)	2 (4%)
	Pulmonary embolism	2 (4%)	0
	Other peripheral venous thrombosis	1 (2%)	1 (2%)
Major adverse cardiovascular events¶
	Cardiovascular death	1 (2%)	0
	Stroke	1 (2%)	0

Data are n (%); n is number of participants. Data were assessed from days 1 to 28.

^*Patients with multiple occurrences of the same event are counted under the highest severity.

^†Included in the overall mortality together with deaths due to disease progression.

^‡Includes Aspergillus infection (n=1) and fungal pneumonia (n=1).

^§Includes patients with at least one positively adjudicated treatment-emergent venous thromboembolic event.

^¶Cardiovascular death event was classified as cardiogenic shock; stroke event was classified as cerebral haemorrhage; no myocardial infarction events were recorded in either treatment group.