Table 2 Side effects and serious adverse events in patients receiving triple therapy
Number | BOC | TPR | P-Value | |
|---|---|---|---|---|
(N = 102) | (N = 37) | (N = 65) | ||
Grade 3/4 anemia | 13 (12.7%)§ | 4 (10.8%) | 9 (13.8%) | 0.77 |
Grade 3/4 neutropenia | 25 (24.5%) | 12 (32.4%) | 13 (20%) | 0.23 |
Grade 3/4 thrombopenia | 14 (13.7%) | 3 (8.1%) | 11 (16.9%) | 0.25 |
Flu-like symptoms | 44 (43.1%) | 20 (54.1%) | 24 (36.9%) | 0.10 |
GI disorders | 43 (42.2%) | 16 (43.2%) | 27 (41.5%) | 1 |
Grade 1/2 rash | 35 (34.3%) | 11 (29.7%) | 24 (36.9%) | 0.52 |
Psychiatric disorder | 29 (28.4%)§§ | 11 (29.7%) | 18 (27.7%) | 1 |
Fatigue | 27 (26.5%) | 15 (40.5%) | 12 (18.5%) | 0.02 |
Anorectal dyscomfort | 25 (24.5%) | 1 (2.7%) | 24 (36.9%)§§§ | <0.01 |
Insomnia | 23 (22.5%) | 7 (18.9%) | 16 (24.6%) | 0.63 |
Bronchopulmonal symptoms | 20 (19.6%) | 9 (24.3%) | 11 (16.9%) | 0.44 |
Dysgeusia | 10 (9.8%) | 9 (24.3%) | 1 (1.5%) | <0.01 |
Immunothyreoiditis | 4 (3.9%) | 0 | 4 (6.2%) | 0.29 |
Serious adverse event | Number | Comments/Outcome | ||
Grade 4 anemia | 2 | Both patients received blood transfusions | ||
Grade 4 neutropenia | 3 | 1 patient with neutropenic sepsis; all 3 recovered after dose reduction of peginterferon | ||
Grade 4 thrombopenia | 6 | 1 patient received a platelet concentrate | ||
Grade 3 rash | 4 | TPR was discontinued early in 1 patient | ||
DRESS/SJS | None | - | ||
Neurological symptoms | 2 | Radial nerve paresis (recovery after physiotherapy) and urine incontinency (ongoing) | ||
Localized infections | 3 | All fully recovered (balanitis, epididymitis, perspiratory gland abscess) | ||
Sepsis | 4 | 2 patients recovered; 2 patients died | ||
Hepatic decompensation | 2 | Both recovered, but 1 patient died 6 weeks after discontinuation of treatment | ||
Decompensation of autoimmune disorder | 1 | First manifestation of autoimmune diabetes mellitus. | ||
Ileus | 2 | Fully recovered after surgical intervention (1x) or conservative treatment (1x) | ||
Cardiac complications | 1 | Unstable angina pectoris, full recovery after PTCA with stent implantation | ||