Table 5.

Summary of treatment‐emergent adverse events (TEAEs)

Patients with:		BMS‐986231 treatment dosage
	Placebo group (n = 12)	3 µg/kg/min (n = 6)	5 µg/kg/min (n = 9)	7 µg/kg/min (n = 12)	12 µg/kg/min (n = 7)	Combined (n = 34)
≥1 TEAE, n (%)	3 (25.0%)	5 (83.3%)	5 (55.6%)	7 (58.3%)	3 (42.9%)	20 (58.8%)
≥2 TEAEs (for combined active treatment) by preferred term, n (%)
Cardiac disorders
Cardiac failure			1 (11.1%)	1 (8.3%)		2 (5.9%)
Cardiac failure, congestive		1 (16.7%)	1 (11.1%)			2 (5.9%)
Nervous system disorders
Headache				2 (16.7%)	1 (14.3%)	3 (8.8%)
Vascular disorders
Hypotension	1 (8.3%)		3 (33.3%)		1 (14.3%)	4 (11.8%)
≥1 serious TEAE, n (%)	1 (8.3%)	3 (50.0%)	1 (11.1%)	3 (25.0%)	1 (14.3%)	8 (23.5%)
Cardiac disorders
Atrial flutter				1 (8.3%)		1 (2.9%)
Atrioventricular block, complete					1 (14.3%)	1 (2.9%)
Cardiac failure				1 (8.3%)		1 (2.9%)
Cardiac failure, congestive		1 (16.7%)	1 (11.1%)			2 (5.9%)
Infections/infestations
Rhinovirus infection		1 (16.7%)a				1 (2.9%)
Metabolism/nutrition disorders
Dehydration	1 (8.3%)					0
Renal and urinary disorders
Renal failure				1 (8.3%)		1 (2.9%)
Respiratory, thoracic and mediastinal disorders
Respiratory failure		1 (16.7%)				1 (2.9%)
Skin and subcutaneous disorders
Toxic epidermal necrolysis		1 (16.7%)				1 (2.9%)
≥1 severe TEAE, n (%)		4 (66.7%)		2 (16.7%)	1 (14.3%)	7 (20.6%)
≥1 fatal TEAE		1 (16.7%)				1 (2.9%)
≥1 drug‐related TEAEb, n (%)	1 (8.3%)		1 (11.1%)	2 (16.7%)	1 (14.3%)	4 (11.8%)
TEAE leading to drug interruption, n (%)						0
TEAE leading to drug discontinuation, n (%)					1 (14.3%)	1 (2.9%)

^aThis patient received study infusion on 23 July 2014 and was diagnosed with Stevens–Johnson syndrome on 13 August 2014, which was empirically considered by the investigator to be iatrogenic and related to the use of the cephalosporin antibiotic for rhinovirus, and not to the study drug.

^bNo reported study drug‐related TEAEs were serious, severe or fatal.