Table II.
Disposition, n (%) | Patients (n =185) |
---|---|
Completed | 62 (33·5) |
Discontinued | 123 (66·5) |
Adverse events | 14 (7·6) |
Abnormal laboratory value/test procedure | 6 (3·2) |
Unsatisfactory therapeutic effect | 6 (3·2) |
No longer requires study drug | 9 (4·9) |
Protocol violation | 3 (1·6) |
Subject withdrew consent | 44 (23·8) |
Lost to follow-up | 17 (9·2) |
Administrative problems | 10 (5·4) |
Death | 3 (1·6) |
Stopped at end of core | 7 (3·8) |
Stopped at end of extension 1* | 4 (2·2) |
Completed 3-year extension study before extension was prolonged to 4 years by protocol amendment