. 2015 Apr 21;4(1):1–15. doi: 10.1007/s40122-015-0034-x

Table 3.

Safety profile of open-label administration of the 5% lidocaine medicated plaster for treatment of postherpetic neuralgia

Any patient with	Pivotal phase 3 trial [18]	Phase 3 long-term trial		Phase 3 non-inferiority trial [19]
	Run-in period	Main period [20]	Extension [21]	Comparative phase	Lidocaine pick-up arm
	Run-in period	Main period [20]	Extension [21]	Comparative phase	Renally impaired^a	Switch^b
	N = 265	N = 249	N = 102	N = 50	N = 30	N = 12
ADR^c	34 (12.8%)	31 (12.4%)	10 (9.8%)	5 (10%)	9 (30%)	2 (16.7%)
Discontinuation due to an ADR	11 (4.2%)	11 (4.4%)	3 (2.9%)	2 (4%)	4 (13.3%)	1 (8.3%)
Serious ADR	0	0	0	1 (2%)	0	0
Discontinuation due to a serious ADR	0	0	0	1 (2%)	0	0

Data are number of patients (%)

^aPatients with a creatinine clearance ≥30 ml/min and ≤60 ml/min at study entry; includes 3 patients erroneously receiving pregabalin in addition to 5% lidocaine medicated plaster

^bSwitched from pregabalin arm during the comparative phase due to tolerability problems

^cConsidered at least possibly related to 5% lidocaine medicated plaster treatment. ADR Drug-related adverse event/adverse drug reaction