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. 2015 Feb 25;33(7):945–953. doi: 10.1007/s00345-015-1505-8

Table 2.

Patient disposition: overall, by study, and by LDI and laterality of treatment

All studies By study By LDI and laterality
PCM201 PCM202 PCM203 LDI < 1 LDI ≥ 1
4 mg/kg 200 J/cm 4 mg/kg 200 J/cm 4 mg/kg 200 J/cm 4 mg/kg 200 J/cm
Unilateral Bilateral Unilateral Bilateral
N = 117 N = 35 N = 21 N = 61 N = 20 N = 18 N = 68 N = 11
Efficacy/safety analysis sets 117 35 21 61 20 18 68 11
Per protocol set 109 29 21 59 18 15 65 11
Discontinued prior to month 6a 2 (1.7) 1 (2.9) 0 1 (1.6) 1 (5.0) 0 1 (1.5) 0
Reason for discontinuation n = 2 n = 1 n = 0 n = 1 n = 1 n = 0 n = 1 n = 0
Withdrew consent 1 (50.0) 0 0 1 (100) 0 0 1 (100) 0
Lack of efficacy 1 (50.0) 1 (100) 0 0 1 (100) 0 0 0

LDI light density index

aPercentages are based on the number of patients included in the safety population