Table 4. Adverse Events, Dose reduction and Treatment Discontinuation in Treated Patients *.
| Parameter | SD48W, N = 94 | SD24W, N = 93 |
|---|---|---|
| Serious AEs | ||
| All† | 4 (4.3) | 3 (3.2) |
| Death | 0 (0) | 0 (0) |
| Treatment-related | 3 (3.2) | 3 (3.2) |
| Treatment withdrawal due to AEs | 11 (11.7) | 6 (6.5) |
| Dose reduction to AEs | ||
| Peginterferon | 23 (24.5) | 20 (21.5) |
| Ribavirin | 45 (47.9) | 35 (37.6) |
| Constitutional AEs | ||
| Flu-like symptoms | 29 (30.9) | 27 (29.0) |
| Fatigue | 57 (60.6) | 54 (58.1) |
| Headache | 26 (27.7) | 28 (30.1) |
| Insomnia | 34 (36.2) | 33 (35.5) |
| Irritability | 11 (11.7) | 10 (10.8) |
| Depression | 14 (14.9) | 12 (12.9) |
| Anorexia | 30 (31.9) | 27 (29.0) |
| Diarrhea | 12 (12.8) | 12 (12.9) |
| Constipation | 11 (11.7) | 8 (8.6) |
| Cough | 14 (14.9) | 15 (16.1) |
| Dermatitis | 28 (29.8) | 25 (26.9) |
| Injection site reaction | 15 (16.0) | 13 (14.0) |
| Hair loss/alopecia | 25 (26.6) | 24 (25.8) |
| Laboratory AEs‡ | ||
| Anemia (week 1–6)§ | 7 (7.4) | 6 (6.5) |
| Hemoglobin level: 8.5–9.9 g/dL | 6 (6.4) | 5 (5.4) |
| Hemoglobin level: <8.5 g/dL | 1 (1.1) | 1 (1.1) |
| Anemia (week 6 to end-of-treatment)§ | 42 (44.7) | 32 (34.4) |
| Hemoglobin level: 8.5–9.9 g/dL | 27 (28.7) | 22 (23.7) |
| Hemoglobin level: <8.5 g/dL | 15 (16.0) | 10 (10.8) |
| Neutropenia | 17 (18.1) | 14 (15.1) |
| Neutrophil count: 0.500–0.749 × 109 cells/L | 13 (13.8) | 11 (11.8) |
| Neutrophil count: <0.500 × 109 cells/L | 4 (4.3) | 3 (3.2) |
| Thrombocytopenia | 9 (9.6) | 11 (11.8) |
| Platelet count: 25–49 × 109 cells/L | 8 (8.5) | 10 (10.8) |
| Platelet count: <25 × 109 cells/L | 1 (1.1) | 1 (1.1) |
| ALT elevation | ||
| >2 times ULN | 16 (17.0) | 18 (19.4) |
| >5 times ULN | 2 (2.1) | 3 (3.2) |
| Total bilirubin elevation¶ | ||
| >2 mg/dL | 5 (5.3) | 4 (4.3) |
| >5 mg/dL | 0 (0.0) | 0 (0.0) |
AE: adverse event, ALT: alanine aminotransferase, ULN: upper limit of normal.
*Values are numbers (percentages).
†SD48W arm: spontaneous bacterial peritonitis at week 36 of treatment, cellulitis at week 20 of treatment, severe anemia with postural dizziness at week 12 of treatment (hemoglobin level: 7.1 g/dL), and multiple myeloma at week 40 of treatment. SD24W arm: urinary tract infection at week 12 of treatment, community-acquired pneumonia at week 16 of treatment, severe anemia with postural dizziness at week 16 of treatment (hemoglobin level: 7.3 g/dL), respectively. All except the patients developing multiple myeloma were considered treatment-related.
‡The grading of the laboratory AEs was shown for patients with the on-treatment nadir level.
§Anemia was defined as a nadir hemoglobin level <10.0 g/dL.
¶No patient with total bilirubin elevation had concomitant ALT elevation >5 times ULN.