Adverse events, dose reduction and treatment discontinuation in treated patients*
| Variable | Peginterferon+ ribavirin (N=86) | Peginterferon (N=86) |
|---|---|---|
| Serious AEs | ||
| All† | 3 (3) | 3 (3) |
| Death | 0 (0) | 0 (0) |
| Treatment-related | 3 (3) | 3 (3) |
| Treatment withdrawal due to AEs‡ | 5 (6) | 3 (3) |
| Dose reduction to AEs | 70 (81) | 33 (38) |
| Peginterferon | 31 (36) | 33 (38) |
| Ribavirin | 60 (70) | – |
| Blood transfusion§ | 1 (1) | 0 (0) |
| Constitutional AEs | ||
| Flu-like symptoms | 21 (24) | 22 (25) |
| Fatigue | 46 (54) | 44 (51) |
| Headache | 22 (26) | 20 (23) |
| Insomnia | 27 (31) | 28 (32) |
| Irritability | 10 (12) | 9 (11) |
| Depression | 11 (13) | 11 (13) |
| Anorexia | 19 (22) | 17 (20) |
| Diarrhoea | 11 (13) | 10 (12) |
| Constipation | 7 (8) | 6 (7) |
| Cough | 13 (15) | 10 (12) |
| Dermatitis | 20 (23) | 18 (21) |
| Injection site reaction | 13 (15) | 14 (16) |
| Hair loss/alopecia | 20 (23) | 21 (24) |
| Laboratory AEs¶ | ||
| Anaemia** | 60 (70) | 7 (8) |
| Haemoglobin level: 8.0–8.4 g/dL | 34 (40) | 6 (7) |
| Haemoglobin level: 7.5–7.9 g/dL | 15 (17) | 1 (1) |
| Haemoglobin level: 7.0–7.4 g/dL | 8 (9) | 0 (0) |
| Haemoglobin level: < 7.0 g/dL | 3 (3) | 0 (0) |
| Neutropenia | 15 (17) | 13 (15) |
| Neutrophil count: 0.500–0.749×109 cells/L | 12 (14) | 10 (12) |
| Neutrophil count: <0.500×109 cells/L | 3 (3) | 3 (3) |
| Thrombocytopenia | 10 (12) | 10 (12) |
| Platelet count: 25–49×109 cells/L | 9 (10) | 10 (12) |
| Platelet count: < 25×109 cells/L | 1 (1) | 0 (0) |
*Values are numbers (percentages).
†Combination therapy: anaemia with postural dizziness in one (treatment week 12), intractable diarrhoea in one (treatment week 16) and pneumonia in one (treatment week 20). Monotherapy: pneumonia in one (treatment week 12), biliary tree infection in one (treatment week 16) and major depression in one (treatment week 20). All serious AEs were considered treatment-related.
‡Including three patients in each group with SAE; another two patients in the combination therapy group stopped treatment at treatment week 20 due to fatigue and insomnia, respectively.
§Packed erythrocyte transfusion of eight units for one patient receiving combination therapy due to anaemia with postural dizziness at treatment week 12 of therapy (haemoglobin level was 6.8 g/dL at time of transfusion).
¶The grading of the laboratory AEs was shown for patients with the on-treatment nadir level.
**Anaemia was defined as a nadir haemoglobin level <8.5 g/dL. Mean epoetin β dosages (SD): 13 417(7219) vs 6667 (2581) IU per week, p=0.027, and mean duration of epoetin β (SD): 10 (5) vs 7 (3) weeks, p=0.065, for patients receiving combination therapy and monotherapy, respectively.
AE, adverse event.