. 2009 May 5;3(5):e432. doi: 10.1371/journal.pntd.0000432

Table 4. Immediate & Delayed Local & Systemic Toxicity.

REACTION	WR279,396 Group (N = 50)		Placebo-Vehicle Group (N = 42)
	Participant with reaction – no (%)	Mean duration (days)	Participant with reaction – no (%)	Mean duration (days)
IMMEDIATE⁰
LOCAL PAIN¹	7 (14.0)	3.1	6 (14.2)	3.3
Mild	7 (14.0)	3.1	6 (14.2)	3.3
Moderate	0 (0.0)	0	0 (0.0)	0
Severe	0 (0.0)	0	0 (0.0)	0
LOCAL ERYTHEMA²	15 (30.0)	7.7	10 (23.8)	8.8
Mild	15 (30.0)	6.4	10 (23.8)	7.7
Moderate	5 (10.0)	3.4	2 (4.8)	4.5
Severe	1 (2.0)	2.0	0 (0.0)	0
LOCAL EDEMA²	1 (2.0)	10.0	2 (4.8)	5.0
Mild	1 (2.0)	6.0	2 (4.8)	5.0
Moderate	1 (2.0)	2.0	0 (0.0)	0
Severe	1 (2.0)	2.0	0 (0.0)	0
SYSTEMIC REACTION	1 (2.0)	1.0	1 (2.4)	2.0
Vertigo	0 (0.0)	0	1 (2.4)	2.0
Tinnitus	1 (2.0)	1.0	0 (0.0)	0
Hearing	0 (0.0)	0	0 (0.0)	0
DELAYED⁰
LOCAL PAIN	9 (18.0)	1.6	5 (11.9)	3.2
Mild	9 (18.0)	1.6	5 (11.9)	3.2
Moderate	0 (0.0)	0	0 (0.0)	0
Severe	0 (0.0)	0	0 (0.0)	0
LOCAL ERYTHEMA	15 (30.0)	7.8	11 (26.2)	8.0
Mild	15 (30.0)	6.5	10 (23.8)	7.8
Moderate	4 (8.0)	4.3	3 (7.1)	3.3
Severe	1 (2.0)	2.0	0 (0.0)	0
LOCAL EDEMA	1 (2.0)	11.0	3 (7.1)	3.7
Mild	1 (2.0)	7.0	3 (7.1)	3.7
Moderate	1 (2.0)	2.0	0 (0.0)	0
Severe	1 (2.0)	2.0	0 (0.0)	0
SYSTEMIC REACTION	0 (0.0)	0	2 (4.8)	1.5
Vertigo	0 (0.0)	0	2 (4.8)	1.5
Tinnitus	0 (0.0)	0	0 (0.0)	0
Hearing	0 (0.0)	0	0 (0.0)	0

⁰

Immediate: observed within 30 minutes of application Delayed : Observed just prior to next application.

Mild pain: does not interfere with daily activity, Moderate pain: interferes with daily activity, Severe pain: daily activities are interrupted.

Mild: barely perceptible erythema or edema, Moderate: well defined erythema or edema, Severe: very red erythema with raised >2 mm edema.