Table 1.
Disposition of subjects during the extension study
| Original cinacalceta (n = 334) | Original placebo (n = 255) | |
|---|---|---|
| Enrolled in extension study, n | 334 | 255 |
| Did not receive study medication, n (%) | 1 (<1) | 3 (1) |
| Received study medication, n (%) | 333 (100) | 252 (99) |
| Titration phase—weeks 1–8, n (%) | ||
| Started | 333 (100) | 252 (99) |
| Discontinued | 15 (4) | 18 (7) |
| Completed | 318 (95) | 234 (92) |
| Maintenance phase—weeks 9–32, n (%) | ||
| Started | 318 (95) | 234 (92) |
| Discontinued | 56 (17) | 50 (20) |
| Completed | 262 (78) | 184 (72) |
| Follow-up phase—weeks 33–164, n (%) | ||
| Startedb | 261 (78) | 182 (71) |
| Discontinued | 136 (41) | 103 (40) |
| Completed | 125 (37) | 79 (31) |
| Total discontinued | 209 (63) | 176 (69) |
| Subjects rolled over to extension study, n (%) | ||
| After 6 moc | 236 (71) | 150 (59) |
| After 12 mod | 98 (29) | 105 (41) |
All subjects who had 26 to 52 wk of cinacalcet therapy prior to study entry.
One original cinacalcet and two original placebo subjects completed maintenance phase and did not start follow-up phase.
Subjects completing studies A, B, and C.
Subjects completing studies D and E.