Table 1. Havrix-specific adverse events.
| Adverse Event | Count | PRR | Chi-square |
|---|---|---|---|
| Behavioral and neurological AE | |||
| Paraplegia* | 4 | 8.32 | 24.58 |
| Complex regional pain syndrome | 3 | 6.32 | 12.95 |
| Impaired work ability | 6 | 2.31 | 4.39 |
| Oral discomfort | 3 | 6.73 | 14.10 |
| Paresis | 4 | 2.92 | 4.96 |
| Pelvic pain | 13 | 14.31 | 148.59 |
| Polymyalgia rheumatica | 3 | 3.88 | 6.27 |
| Cardiovascular AE | |||
| Anaphylactic shock* | 4 | 2.71 | 4.39 |
| Circulatory shock* | 6 | 2.82 | 6.95 |
| Decreased heart rate | 8 | 3.28 | 12.47 |
| Hypotension | 11 | 2.16 | 6.78 |
| Eye AE | |||
| Ocular icterus | 3 | 10.89 | 25.33 |
| Double vision | 7 | 2.18 | 4.36 |
| Gustatory system AE | |||
| Anorexia | 18 | 2.14 | 10.87 |
| Hair, skin or nail AE | |||
| Dry skin | 6 | 2.33 | 4.49 |
| Hematopoietic system AE | |||
| Eosinophilia | 3 | 4.16 | 7.04 |
| Hepatobiliary or pancreatic AE | |||
| Jaundice | 12 | 5.33 | 41.04 |
| Liver disorder | 4 | 4.81 | 11.73 |
| Homeostasis AE | |||
| Eye edema | 4 | 3.26 | 6.17 |
| Immune system AE | |||
| Hepatitis A* | 13 | 19.62 | 206.22 |
| Osteoarthritis* | 4 | 3.94 | 8.60 |
| Vasculitis* | 7 | 3.22 | 10.53 |
| Allergic rhinitis | 3 | 2.82 | 6.95 |
| Hepatitis | 8 | 5.05 | 25.31 |
| Investigation result abnormal AE | |||
| Alanine aminotransferase level increased | 39 | 5.90 | 154.61 |
| Aspartate aminotransferase level increased | 29 | 4.42 | 75.25 |
| Blood bilirubin level increased | 10 | 4.09 | 22.86 |
| Gamma-glutamyltransferase level increased | 15 | 8.02 | 88.22 |
| Hepatic enzyme increased | 8 | 5.29 | 27.03 |
| Transaminase level increased | 3 | 3.18 | 4.40 |
| Musculoskeletal and connective tissue AE | |||
| Fasciitis | 6 | 4.14 | 13.99 |
| Fibrosis tendinous | 4 | 6.15 | 16.65 |
| Myofascitis | 7 | 7.70 | 39.10 |
| Pregnancy, neonatal or perinatal disorder AE | |||
| Abortion* | 4 | 4.81 | 11.73 |
| Abortion missed* | 3 | 9.30 | 21.09 |
| Abortion spontaneous* | 29 | 6.07 | 119.19 |
| Premature labor* | 5 | 5.43 | 17.54 |
| Unintended pregnancy | 30 | 17.96 | 435.41 |
| Reproductive system AE | |||
| Ovarian cyst | 3 | 5.02 | 9.38 |
| Placental disorder | 3 | 15.99 | 38.56 |
| Vaginal hemorrhage | 26 | 14.88 | 310.28 |
| Sexual dysfunctions | 3 | 11.12 | 25.96 |
| Respiratory system AE | |||
| Painful respiration | 3 | 4.13 | 6.95 |
| Urinary system AE | |||
| Urinary incontinence* | 9 | 2.46 | 7.69 |
| Chromaturia | 4 | 4.16 | 9.38 |
| Nephrotic syndrome | 3 | 5.67 | 11.22 |
*Serious adverse event (SAE).