Table 4.
Side effects | Overall1 | PEG-IFN co-treatment2 | IFN-free treatment3 | P value | |||
Fatigue | 93 | 39.2% | 26 | 54.2% | 67 | 35.4% | 0.020 |
Cephalgia | 52 | 21.9% | 9 | 18.8% | 43 | 22.8% | 0.697 |
Bone/joint pain/myalgia | 38 | 16.0% | 12 | 25.0% | 26 | 13.8% | 0.077 |
Nausea/vomiting | 38 | 16.0% | 14 | 29.2% | 24 | 12.7% | 0.008 |
0.163 | |||||||
Insomnia | 28 | 11.8% | 16 | 33.3% | 12 | 6.3% | < 0.0001 |
Vertigo | 16 | 6.8% | 6 | 12.5% | 10 | 5.3% | 0.102 |
Flu-like symptoms | 14 | 5.9% | 12 | 25.0% | 2 | 1.1% | < 0.0001 |
Abdominal discomfort/pain | 17 | 7.2% | 3 | 6.3% | 15 | 7.9% | 1.000 |
Pruritus | 18 | 7.6% | 4 | 8.3% | 13 | 6.9% | 0.755 |
Diarrhea | 13 | 5.5% | 7 | 14.6% | 6 | 3.2% | 0.006 |
Any rash | 14 | 5.9% | 7 | 14.6% | 7 | 3.7% | 0.010 |
Anorexia | 9 | 3.8% | 4 | 8.3% | 5 | 2.6% | 0.085 |
Nervousness | 7 | 3.0% | 4 | 8.3% | 3 | 1.6% | 0.033 |
Depression/fear | 5 | 2.1% | 2 | 4.2% | 3 | 1.6% | 0.267 |
Dyspnoea | 7 | 3.0% | 4 | 8.3% | 3 | 1.6% | 0.030 |
Concentration weakness | 4 | 1.7% | 2 | 4.2% | 2 | 1.1% | 0.183 |
Visual changes | 4 | 1.7% | 1 | 2.1% | 3 | 1.6% | 1.000 |
Loss of hair | 4 | 1.7% | 1 | 2.1% | 3 | 1.6% | 1.000 |
Tachycardia/palpitations | 2 | 0.8% | 2 | 4.3% | 0 | 0.0% | 0.040 |
Meteorism | 3 | 1.3% | 0 | 0.0% | 3 | 1.6% | 1.000 |
Aggression | 2 | 0.8% | 2 | 4.2% | 0 | 0.0% | 0.040 |
Fever/chills | 1 | 0.4% | 1 | 2.1% | 0 | 0.0% | 0.200 |
Attacks of sweating | 1 | 0.4% | 1 | 2.1% | 0 | 0.0% | 0.200 |
Gingivitis | 1 | 0.4% | 0 | 0.0% | 1 | 0.5% | 1.000 |
Cough | 1 | 0.4% | 1 | 2.1% | 0 | 0.0% | 0.200 |
Neurological symptoms | 1 | 0.4% | 0 | 0.0% | 1 | 0.7% | 1.000 |
Side effect reports were available in 237 of 260 patients;
In PEG-IFN co-treated patients (n = 51), side effect reports were available in 48 patients;
In IFN-free treated patients (n = 209), side effects reports were available in 189 patients. Significant calculations (P < 0.05) are printed in bold. IFN: Interferon.