TABLE 4. Incidence and Severity of PSCsa.
Parameter | SoC | CIB |
---|---|---|
Annual probability of PSC | 55% (41/74) | 41% (32/79) |
Proportion of patients who experience a second PSC, among patients who already experienced a PSC, without addition of accessory | 15% | 10% |
Reduction in the incidence of a second PSC with the addition of an accessoryb | 50% | 50% |
Probability first PSC is mild | 69% (28/41) | 72% (23/32) |
Probability first PSC is moderate | 29% (12/41) | 25% (8/32) |
Probability first PSC is severe | 2% (1/41) | 3% (1/32) |
Probability second PSC is mild, given first PSC is mild | 0% (0/1) | 33%c |
Probability second PSC is moderate, given first PSC is mild | 100% (1/1) | 33%c |
Probability second PSC is severe, given first PSC is mild | 0% (0/1) | 34%c |
Probability second PSC is mild, given first PSC is moderate | 0% (0/1) | 33%c |
Probability second PSC is moderate, given first PSC is moderate | 100% (1/1) | 33%c |
Probability second PSC is severe, given first PSC is moderate | 0% (0/1) | 34%c |
Probability second PSC is mild, given first PSC is severe | 33%c | 33%c |
Probability second PSC is moderate, given first PSC is severe | 33%c | 33%c |
Probability second PSC is severe, given first PSC is severe | 34%c | 34%c |
Abbreviations: CIB, ceramide-infused skin barrier; PSC, peristomal skin complication; SoC, standard of care.
aNumerators and denominators are in parentheses.
bADVOCATE Study did not provide input on this parameter. Both ceramide-infused skin barrier and SoC values were assumed to be 50% to be conservative.
cNo values were observed in ADVOCATE; these values are assumptions.