Table 5.

Incidence of treatment-emergent application site-related adverse events

Adverse event, n (%)	Diclofenac topical solution (n = 465)	Oral diclofenac (n = 462)	P value
Any application site-related adverse event	135 (29.0)	28 (6.1)	<0.0001*
Skin and subcutaneous tissue disorders
Overall	134 (28.8)	23 (5.0)	<0.0001*
Dry skin	112 (24.1)	9 (1.9)	<0.0001*
Pruritus	23 (4.9)	9 (1.9)	0.01†
Dermatitis contact	20 (4.3)	3 (0.6)	0.0004†
Rash	10 (2.2)	6 (1.3)	0.32
Urticaria	2 (0.4)	2 (0.4)	>0.99
Nervous system disorders
Paresthesia	6 (1.3)	6 (1.3)	1.0

Notes:

^*From Chi-square test;

^†From Fisher’s exact test.