Table 2.
Patient disposition across all treatment groups at the data cutoff date for each studya.
| Study INCB 54329-101 (n = 69) | Study INCB 57643-101 (n = 134) | |
|---|---|---|
| Patient treated, n (%) | ||
| Ongoing | 0 | 8 (6) |
| Discontinued | 69 (100) | 126 (94) |
| Primary reason for discontinuation, n (%) | ||
| Disease progression | 53 (77) | 76 (57) |
| Withdrew consent | 5 (7) | 9 (7) |
| Physician decision | 3 (4) | 10 (7) |
| Adverse event | 2 (3) | 20 (15) |
| Other | 4 (6)b | 2 (1)c |
| Lost to follow-up | 1 (1) | 0 |
| Death | 1 (1) | 9 (7) |
a
Data cutoff dates: study INCB 54329-101 - April 11, 2018; study INCB 57643-101-September 24, 2018.
b
One patient had clinical progression; 1 patient developed a new tumor; 2 patients discontinued treatment due to study closure.
c
One patient came off treatment as the study treatment was on hold for more than 14 days; 1 patient had clinical progression of skin lesions.