Table II.

Side-effects observed during PAT-SC1 treatment.

System Organ Class	Grade 1	Grade 2	Grade 3	Grade 4	All grades
Preferred Term	n (%)	n (%)	n (%)	n (%)	n (%)
Cardiac disorders	4 (7.8)				4 (7.8)
Bradycardia NOS	2 (3.9)				2 (3.9)
Tachycardia NOS	2 (3.9)				2 (3.9)
Gastrointestinal disorders	1 (2.0)				1 (2.0)
Nausea	1 (2.0)				1 (2.0)
General disorders and administration side conditions	13 (25.5)	1 (2.0)			14 (27.5)
Application site cold feeling	4 (7.8)	1 (2.0)			4 (7.8)
Pyrexia	7 (13.7)				8 (15.7)
Rigors	2 (3.9)				2 (3.9)
Immune system disorders	1 (2.0)	1 (2.0)			2 (3.9)
Anaphylactic reaction	1 (2.0)	1 (2.0)			2 (3.9)
Musculoskeletal and connective tissue disorders	3 (5.9)				3 (5.9)
Arthralgia	1 (2.0)				1 (2.0)
Back pain	1 (2.0)				1 (2.0)
Groin pain	1 (2.0)				1 (2.0)
Nervous system disorders	4 (7.8)				4 (7.8)
Dizziness	1 (2.0)				1 (2.0)
Headache	3 (5.9)				3 (5.9)
Vascular disorders	6 (11.8)	1 (2.0)			7 (13.7)
Cyanosis peripheral	1 (2.0)				1 (2.0)
Hypertension NOS	2 (3.9)				2 (3.9)
Hypotension NOS	3 (5.9)	1 (2.0)			4 (7.8)

Note, no grade 3 or 4 side-effects were observed, NOS, not otherwise specified.