CTP | No. | Visit Month | Overall N (%) | ||||
---|---|---|---|---|---|---|---|
2 | 4 | 6 | 9 | 12 | |||
Intent to treat | |||||||
A | 12 | 0 (1) | 1 (3) | 2 (1) | 3 (0) | 5 (1*) | 5 (42) |
B | 23 | 1 (3) | 1 (5) | 5 (5*) | 7 (7*) | 10 (2*) | 10 (43.5) |
C | 9 | 4 (0) | 6 (1) | 6 (0) | 6 (1*) | 6 (1*) | 6 (67) |
Censored for treatment failures | |||||||
A | 8 | 0 (1) | 1 (3) | 2 (1) | 3 (0) | 4 (0) | 4 (50) |
B | 17 | 1 (2) | 1 (5) | 5 (5*) | 7 (6*) | 10 (2*) | 10 (59) |
C | 8 | 4 (0) | 6 (1) | 6 (0) | 6 (1) | 6 (1*) | 6 (75) |
To track improvement in PGA-A scores across visits, the total no. patients who had achieved a PGA-A of 0 at each study visit after baseline were counted. The total number of patients who had achieved a PGA-A score of 0 by this visit are listed and the number of patients who were missing at each visit and had not yet reached a PGA-A score of 0 is noted in parantheses. Followup visits were specified to occur within 1 month of target time of 2 months, 4 months, 6 months, 9 months, and 12 months. The top panel shows the values for all patients who were receiving systemic immunosuppressive treatment at last study visit based upon the initially prescribed CTP; the bottom panel excludes the 11 patients who experienced treatment failure. A number of patients in CTP B missed their 4-, 6-, and/or 9-month visits; however, at 12-month visit, the only missing data were due to censoring. In CTP A, data from 1 patient was censored at the 12-month visit because of dropout due to treatment failure; this patient is represented only in the top panel. In CTP B, data from 2 patients were censored at the 6-month visit, and in CTP C data from 1 patient was censored at the 9-month visit, because of treatment discontinuation secondary to adverse events.