TABLE 2.
Adverse events (AEs), laboratory abnormalities and dosage modifications
|
Treatment setting |
||
|---|---|---|
| Academic (n=133) | Community (n=250) | |
| Withdrawal from treatment for AEs and/or laboratory abnormalities | 14 (10.5) | 25 (10.0) |
| Serious AEs | 6 (5.1) | 27 (11.8) |
| Serious AEs related to study medication* | 3 (2.5) | 17 (7.4) |
| Deaths | 0 | 2 (0.8) |
| Laboratory abnormalities | ||
| Hemoglobin <100 g/L | 12 (9.0) | 29 (11.6) |
| Neutrophils <0.75×109/L | 13 (9.8) | 32 (12.8) |
| Platelets <50×109/L | 4 (3.0) | 14 (5.6) |
| Dosage reductions | ||
| Peginterferon alfa-2a | 6 (4.5) | 11 (4.4) |
| Ribavirin | 15 (11.3) | 22 (8.8) |
| Discontinuation† | ||
| Peginterferon alfa-2a | 82 (61.7) | 122 (48.8) |
| Ribavirin | 81 (60.9) | 124 (49.6) |
Data presented as n (%).
*
Possibly, probably or definitely related to study drug in the opinion of the investigator;
†
Includes patients discontinued for any reason including lack of response, adverse events or laboratory abnormalities