Table 2.
Patient disposition
Disposition | Primary study (N = 64) | Extension study (N = 19) |
---|---|---|
Idelalisib dose regimen, n (%) | ||
50 mg BID | 7 (11) | 0 |
150 mg QD | 9 (14) | 3 |
150 mg BID (3 wk on, 1 wk off) | 12 (19) | 1 |
100 mg BID | 7 (11) | 3 |
300 mg QD | 5 (8) | 3 |
150 mg BID | 10 (15) | 3 |
200 mg BID | 10 (15) | 4 |
350 mg BID | 4 (6) | 2 |
Completed study (≥48 wk), n (%) | 19 (30) | 1 ongoing |
Discontinued, n (%) | 45 (70) | 18 (95) |
Disease progression | 23 (36) | 9 (47) |
AE | 8 (13) | 4 (21) |
Patient/investigator request | 2 (3) | 2 (11) |
Withdrew consent | 2 (3) | 0 |
Prohibited drug | 1 (2) | 0 |
Patient noncompliance | 1 (2) | 0 |
Death | 0 | 1 (5) |
Other* | 8 (13) | 2 (11) |
Other in primary study includes: investigator decision/mild progression, need of additional therapy, deterioration of functional status, limited benefit; poor tolerance, patient decision/head injury; difficulty with transportation, and incarceration.