Table 2. Exposure.
|
24-Week double-blind period |
48-Week open-label DAR |
|||
|---|---|---|---|---|
| Placebo (n=48) | DAR (n=98) | Prior placebo (n=38) | Prior DAR (n=87) | |
| Received all eight doses | 37 (77) | 77 (79) | NA | NA |
| Number of doses received | NA | 8 (1–8) | 20 (3–23) | 19 (1–23) |
| Average dose (μg) | NA | 500 (25–500) | 500 (300–500) | 500 (193–500) |
| Dose reduced due to rapid Hgb rise | ||||
| Once | 0 | 16 (16) | 7 (18) | 18 (21) |
| Twice | 0 | 2 (2) | 5 (13) | 11 (13) |
| 3 Times | 0 | 0 | 5 (13) | 3 (3) |
| 4 Times | 0 | 0 | 1 (3) | 0 |
| In patients who also had HI-E | 0 | 4 (4) | 9 (24) | 18 (21) |
| Hgb for dose reduction, g/dl | NA | 10.6 (8.4–12) | 10.6 (8.5–11.9) | 10.6 (8.5–11.9) |
| Dose not administered | ||||
| Withheld as Hgb >12 g/dl | 0 | 11 (11)a | 12 (32) | 24 (28) |
| Doses withheld in patients who also had HI-E | 0 | 4 (4) | 8 (21) | 18 (21) |
| Adverse event | 5 (10) | 2 (2) | 1 (3) | 7 (8) |
| Noncompliance | 0 | 1 (1) | 6 (16) | 12 (14) |
| Other | 1 (2)b | 2 (2)c | 4 (11)d | 12 (14)e |
Abbreviations: DAR, darbepoetin alfa; Hgb, hemoglobin; HI-E, hematologic improvement-erythroid response; IP, investigational product; NA, not applicable.
Data are median (min–max) or n (%).
a
Dose was withheld once for six patients, twice for four patients, and three times for one patient.
b
No IP on site.
c
Reasons for other were investigator decision and no IP on site.
d
Other included unknown (n=3) and no IP on site (n=1).
e
Other included unknown (n=7) and one each of investigator decision, patient unable to go to clinic, interactive voice response system malfunction, investigator concern regarding high Hgb value and investigator felt there was a lack of efficacy.