Table 1.
Summary of Subject Disposition, Overall n = 66 (Safety Analysis Set)
| Proposed | Pegfilgrastim | ||
|---|---|---|---|
| Pegfilgrastim | Reference | Overall, | |
| Description | Biosimilar, n (%) | Product, n (%) | n (%) |
| Subjects receiving medication (population safety analysis set) | 60 (90.91) | 63 (95.45) | 66 (100) |
| Subjects completing study (PK/PD population) | 56 (84.85) | 56 (84.85) | 56 (84.85) |
| Reasons for discontinuation | |||
| Discontinued for any reason | 4 (6.06) | 6 (9.09) | 10 (15.15) |
| Dismissed because of adverse event | 1 (1.52) | 2 (3.03) | 3 (4.55) |
| Dismissed because of noncompliance with study drug | 1 (1.52) | 3 (4.55) | 4 (6.06) |
| Withdrawal by subject | 1 (1.52) | 0 | 1 (1.52) |
| Withdrawn for PK/PD reasonsa | 1 (1.52) | 1 (1.52) | 2 (3.03) |
Subjects were withdrawn prior to the completion of the clinical phase and hence prior to PK/PD analysis.