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