Table 3. Twinrix-specific adverse events.
| Adverse Event | Count | PRR | Chi-square |
|---|---|---|---|
| Behavioral and neurological AE | |||
| Monoplegia* | 5 | 2.41 | 4.04 |
| Quadriplegia* | 4 | 3.98 | 8.57 |
| Facial paresis | 11 | 2.97 | 14.02 |
| Hypoesthesia facial | 12 | 2.34 | 9.01 |
| Impaired driving ability | 5 | 3.18 | 7.22 |
| Impaired work ability | 12 | 2.70 | 12.50 |
| Monoparesis | 4 | 4.47 | 10.32 |
| Paraparesis | 5 | 7.03 | 24.15 |
| Paresis | 13 | 5.69 | 47.53 |
| Pelvic pain | 7 | 4.28 | 16.87 |
| Performance status decreased | 6 | 36.91 | 152.45 |
| Sensory disturbance | 24 | 3.03 | 31.87 |
| Vertigo | 33 | 2.30 | 23.82 |
| Cardiovascular AE | |||
| Anaphylactic shock* | 8 | 3.23 | 11.92 |
| Circulatory collapse* | 16 | 6.91 | 75.63 |
| Hematoma | 9 | 2.375 | 7.01 |
| Cardiovascular disorder | 13 | 10.40 | 99.99 |
| Sinus tachycardia | 4 | 2.68 | 4.10 |
| Digestive AE | |||
| Eructation | 4 | 4.98 | 12.13 |
| Feces pale | 6 | 6.95 | 28.55 |
| Eye AE | |||
| Ocular icterus | 4 | 8.56 | 24.57 |
| Double vision | 14 | 2.53 | 12.70 |
| Eye hemorrhage | 4 | 7.29 | 20.22 |
| Ophthalmoplegia | 6 | 6.42 | 25.78 |
| Pupils unequal | 4 | 8.20 | 23.35 |
| Visual disturbance | 21 | 3.90 | 43.70 |
| Hematopoietic system AE | |||
| Leukopenia | 5 | 2.51 | 4.44 |
| Splenomegaly | 6 | 4.96 | 18.08 |
| Hepatobiliary or pancreatic AE | |||
| Hepatic steatosis* | 9 | 2.38 | 7.01 |
| Hepatomegaly* | 5 | 3.37 | 8.07 |
| Cholelithiasis | 5 | 9.11 | 33.06 |
| Cholestasis | 4 | 17.89 | 53.99 |
| Jaundice | 37 | 10.14 | 277.12 |
| Liver disorder | 10 | 7.24 | 50.11 |
| Homeostasis AE | |||
| Laryngeal edema | 4 | 3.90 | 8.29 |
| Immune system AE | |||
| Autoimmune thyroiditis* | 4 | 5.54 | 14.11 |
| Hepatitis A* | 21 | 19.68 | 310.58 |
| Hepatitis B* | 6 | 3.86 | 12.24 |
| Hepatosplenomegaly* | 5 | 9.28 | 33.79 |
| Leukocytoclastic vasculitis* | 4 | 4.23 | 9.48 |
| Multiple sclerosis* | 27 | 3.33 | 42.79 |
| Psoriasis* | 4 | 3.12 | 5.60 |
| Rheumatoid arthritis* | 9 | 2.29 | 6.40 |
| Systemic lupus erythematosus* | 8 | 2.68 | 8.20 |
| Ulcerative colitis* | 4 | 4.58 | 10.69 |
| Vasculitis* | 10 | 2.67 | 10.23 |
| Central nervous system inflammation | 4 | 6.15 | 16.25 |
| Dermatitis allergic | 5 | 3.39 | 8.17 |
| Hepatitis | 19 | 7.22 | 95.01 |
| Lymphocytosis | 4 | 4.80 | 11.48 |
| Investigation result abnormal AE | |||
| Alanine aminotransferase level increased | 73 | 6.68 | 332.31 |
| Aspartate aminotransferase level increased | 93 | 8.53 | 573.00 |
| Blood alkaline phosphatase increased | 21 | 4.90 | 62.22 |
| Blood bilirubin level increased | 30 | 7.44 | 155.81 |
| Blood cholesterol increased | 5 | 2.75 | 5.42 |
| Blood lactate dehydrogenase level increased | 16 | 4.41 | 40.48 |
| Gamma-glutamyltransferase level increased | 59 | 21.11 | 932.75 |
| Hepatic enzyme increased | 35 | 14.91 | 395.11 |
| Monocytosis | 4 | 9.84 | 28.89 |
| Pleocytosis | 6 | 6.56 | 26.53 |
| Transaminase level increased | 14 | 9.19 | 93.49 |
| Musculoskeletal or connective tissue AE | |||
| Arthropathy | 8 | 3.23 | 11.92 |
| Bone disorder | 4 | 4.47 | 10.32 |
| Myositis | 7 | 2.46 | 5.93 |
| Muscle disorder | 9 | 4.01 | 19.55 |
| Muscular atrophy | 7 | 2.61 | 6.78 |
| Rhabdomyolysis | 4 | 2.96 | 5.04 |
| Nervous system AE | |||
| Myelitis* | 12 | 6.56 | 53.09 |
| Central nervous system lesion | 5 | 2.83 | 5.75 |
| Demyelination | 13 | 2.59 | 12.40 |
| Dysesthesia | 6 | 3.69 | 11.36 |
| Formication | 6 | 3.89 | 12.38 |
| Optic neuritis | 15 | 4.18 | 34.91 |
| Polyneuropathy | 10 | 4.90 | 29.57 |
| Pregnancy, neonatal or perinatal AE | |||
| Abortion* | 5 | 3.49 | 8.59 |
| Premature delivery* | 4 | 6.56 | 17.68 |
| Reproductive system AE | |||
| Vaginal hemorrhage | 14 | 4.44 | 35.83 |
| Respiratory system AE | |||
| Hyperventilation | 9 | 2.11 | 5.19 |
| Lung DISORDER | 7 | 2.75 | 7.56 |
| Tumor AE | |||
| Lymphoma* | 4 | 9.84 | 28.89 |
| Urinary system AE | |||
| Chromaturia | 12 | 7.57 | 63.61 |
| Proteinuria | 6 | 3.14 | 8.49 |
*Serious adverse event (SAE).