Table 1.

Maximum Local and Systemic Reactogenicity after Administration of CIS43LS According to Dose and Route of Administration.^*

Symptom and Severity	5 mg/kg IV (N = 4)	5 mg/kg SC (N = 4)	20 mg/kg IV (N = 9)†	40 mg/kg IV (N = 12)	All Groups (N = 29)
	number of participants (percent)
Local reactogenicity
Pain and tenderness
None	4 (100)	1 (25)	7 (78)	10 (83)	22 (76)
Mild	0	3 (75)	2 (22)	2 (17)	7 (24)
Pruritus
None	4 (100)	4 (100)	9 (100)	12 (100)	29 (100)
Swelling
None	4 (100)	4 (100)	9 (100)	12 (100)	29 (100)
Redness
None	4 (100)	4 (100)	9 (100)	12 (100)	29 (100)
Bruising
None	4 (100)	4 (100)	9 (100)	11 (92)	28 (97)
Moderate	0	0	0	1 (8)	1 (3)
Any local symptom
None	4 (100)	1 (25)	7 (78)	10 (83)	22 (76)
Mild	0	3 (75)	2 (22)	1 (8)	6 (21)
Moderate	0	0	0	1 (8)	1 (3)
Systemic reactogenicity
Malaise
None	4 (100)	4 (100)	7 (78)	11 (92)	26 (90)
Mild	0	0	2 (22)	0	2 (7)
Moderate	0	0	0	1 (8)	1 (3)
Muscle aches
None	4 (100)	2 (50)	8 (89)	10 (83)	24 (83)
Mild	0	2 (50)	1 (11)	2 (17)	5 (17)
Headache
None	3 (75)	3 (75)	7 (78)	9 (75)	22 (76)
Mild	0	1 (25)	2 (22)	3 (25)	6 (21)
Moderate	1 (25)	0	0	0	1 (3)
Chills
None	4 (100)	4 (100)	9 (100)	12 (100)	29 (100)
Nausea
None	3 (75)	4 (100)	8 (89)	12 (100)	27 (93)
Mild	0	0	1 (11)	0	1 (3)
Moderate	1 (25)	0	0	0	1 (3)
Joint pain
None	4 (100)	4 (100)	9 (100)	11 (92)	28 (97)
Mild	0	0	0	1 (8)	1 (3)
Elevated temperature
None	4 (100)	4 (100)	9 (100)	11 (92)	28 (97)
Mild	0	0	0	1 (8)	1 (3)
Any systemic symptom
None	3 (75)	1 (25)	5 (56)	6 (50)	15 (52)
Mild	0	3 (75)	4 (44)	5 (42)	12 (41)
Moderate	1 (25)	0	0	1 (8)	2 (7)

^*IV denotes intravenous, and SC subcutaneous.

^†Data are included for 4 participants who received a second dose of CIS43LS at 20 mg per kilogram of body weight in Part B.