Table 3:

Distribution of patients by highest grade adverse event without regard to attribution

	Nivolumab (n=25) No. and (%) of Patients by Grade
System Organ Class	1	2	3	4	5
Overall Highest Grade	3	6	12	3	0
	(12.0)	(24.0)	(48.0)	(12.0)	(0.0)
Blood and lymphatic system disorders	3	8	3	0	0
	(12.0)	(32.0)	(12.0)	(0.0)	(0.0)
Cardiac disorders	2	0	0	0	0
	(8.0)	(0.0)	(0.0)	(0.0)	(0.0)
Ear and labyrinth disorders	1	0	0	0	0
	(4.0)	(0.0)	(0.0)	(0.0)	(0.0)
Endocrine disorders	3	2	1	0	0
	(12.0)	(8.0)	(4.0)	(0.0)	(0.0)
Eye disorders	0	1	0	0	0
	(0.0)	(4.0)	(0.0)	(0.0)	(0.0)
Gastrointestinal disorders	12	3	5	0	0
	(48.0)	(12.0)	(20.0)	(0.0)	(0.0)
General disorders and administration site conditions	9	8	1	0	0
	(36.0)	(32.0)	(4.0)	(0.0)	(0.0)
Hepatobiliary disorders	0	0	1	0	0
	(0.0)	(0.0)	(4.0)	(0.0)	(0.0)
Infections and infestations	1	5	1	0	0
	(4.0)	(20.0)	(4.0)	(0.0)	(0.0)
Injury, poisoning and procedural complications	1	2	0	0	0
	(4.0)	(8.0)	(0.0)	(0.0)	(0.0)
Investigations	8	3	2	3	0
	(32.0)	(12.0)	(8.0)	(12.0)	(0.0)
Metabolism and nutrition disorders	8	1	5	0	0
	(32.0)	(4.0)	(20.0)	(0.0)	(0.0)
Musculoskeletal and connective tissue disorders	5	10	1	0	0
	(20.0)	(40.0)	(4.0)	(0.0)	(0.0)
Neoplasms benign, malignant and unspecified	0	0	2	0	0
	(0.0)	(0.0)	(8.0)	(0.0)	(0.0)
Nervous system disorders	9	3	1	0	0
	(36.0)	(12.0)	(4.0)	(0.0)	(0.0)
Psychiatric disorders	3	2	0	0	0
	(12.0)	(8.0)	(0.0)	(0.0)	(0.0)
Renal and urinary disorders	4	2	0	0	0
	(16.0)	(8.0)	(0.0)	(0.0)	(0.0)
Reproductive system and breast disorders	3	3	1	0	0
	(12.0)	(12.0)	(4.0)	(0.0)	(0.0)
Respiratory, thoracic and mediastinal disorders	9	2	0	0	0
	(36.0)	(8.0)	(0.0)	(0.0)	(0.0)
Skin and subcutaneous tissue disorders	7	0	0	0	0
	(28.0)	(0.0)	(0.0)	(0.0)	(0.0)
Vascular disorders	1	7	1	0	0
	(4.0)	(28.0)	(4.0)	(0.0)	(0.0)