Table 3.

Adverse events of special interest – all treated participants

Parameter	BMS-936559 treatment						Placebo (n=4)
	10 mg (n=4)	30 mg (n=4)	100 mg (n=4)	300 mg (n=4)	900 mg (n=4)	Pooled (n=20)
AEs of special interest, Grade 3–4; number of participants (%)	0	1 (25)	0	1 (25)	1 (25)	3 (15)	0
Gastrointestinal disorders
Diarrhea	0	0	0	1 (25)	1 (25)	2 (10)	0
Respiratory, thoracic, and mediastinal disorders
Lung infiltration	0	1 (25)	0	0	0	1 (5)	0
AE of special interest, any Grade; number of participants (%)	3 (75)	1 (25)	3 (75)	2 (50)	2 (50)	11 (55)	2 (50)
Gastrointestinal disorders
Diarrhea	2 (50)	0	3 (75)	1 (25)	1 (25)	7 (35)	1 (25)
Endocrine disorders
Hypothyroidism	1 (25)	0	1 (25)	0	0	2 (10)	0
Investigations
AST increased	0	0	0	1 (25)	0	1 (5)	1 (25)
ALT increased	0	0	0	1 (25)	0	1 (5)	0
Respiratory, thoracic, and mediastinal disorders
Lung infiltration	0	1 (25)	0	0	0	1 (5)	0
Skin and subcutaneous tissue disorders
Rash	0	0	0	0	1 (25)	1 (5)	0

All recorded AEs of special interest were summarized by preferred term using Medical Dictionary for Regulatory Activities (MedDRA) Version 20.0. AEs of special interest were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.

AEs of special interest are AEs with potential immune-related causes as identified in the anti-PD-LI study in patients with cancer (35).

AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; n, number of participants.