Table 3.
List of ADRs for infections and infestations, neoplasms benign, malignant, and unspecified (including cysts and polyps), blood and lymphatic system disorders, endocrine disorders, metabolism and nutrition disorders.
| Summary of ADR | Number or ratio |
|---|---|
| Number of study sites | 1,002 |
| Number of patients studied | 3,762 |
| Number of patients with ADRs | 402 |
| Number of ADR episodes | 598 |
| Ratio of patients with ADRs | 10.69% |
|
| |
| Types of ADRs | Number (%) |
|
| |
| Infections and infestations | 16 (0.43) |
| Appendicitis | 1 (0.03) |
| Bronchitis | 5 (0.13) |
| Fungal infection | 1 (0.03) |
| Gastroenteritis | 1 (0.03) |
| Herpes zoster | 2 (0.05) |
| Meningitis bacterial | 1 (0.03) |
| Nasopharyngitis | 2 (0.05) |
| Peritonitis | 1 (0.03) |
| Pneumonia | 2 (0.05) |
| Subcutaneous abscess | 1 (0.03) |
| Psoas abscess | 1 (0.03) |
| Intervertebral discitis | 1 (0.03) |
| Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 6 (0.16) |
| Colon cancer | 1 (0.03) |
| Gastric cancer | 2 (0.05) |
| Metastases to lymph nodes | 1 (0.03) |
| Esophageal carcinoma | 1 (0.03) |
| Uterine cancer | 1 (0.03) |
| Lung neoplasm malignant | 1 (0.03) |
| Blood and lymphatic system disorders | 12 (0.32) |
| Anemia | 3 (0.08) |
| Eosinophilia | 1 (0.03) |
| Iron deficiency anemia | 5 (0.13) |
| Nephrogenic anemia | 4 (0.11) |
| Endocrine disorders | 9 (0.24) |
| Basedow’s disease | 1 (0.03) |
| Hyperparathyroidism secondary | 2 (0.05) |
| Hyperprolactinemia | 5 (0.13) |
| Hyperthyroidism | 1 (0.03) |
| Thyrotoxic crisis | 1 (0.03) |
| Metabolism and nutrition disorders | 23 (0.61) |
| Dehydration | 1 (0.03) |
| Diabetes mellitus | 3 (0.08) |
| Hyperammonemia | 1 (0.03) |
| Hypercalcemia | 1 (0.03) |
| Hyperkalemia | 2 (0.05) |
| Hyperphagia | 1 (0.03) |
| Hyperphosphatemia | 7 (0.19) |
| Hypertriglyceridemia | 1 (0.03) |
| Hyperuricemia | 1 (0.03) |
| Hypocalcemia | 1 (0.03) |
| Hypokalemia | 1 (0.03) |
| Polydipsia | 1 (0.03) |
| Lipid metabolism disorder | 1 (0.03) |
| Malnutrition | 1 (0.03) |
| Decreased appetite | 4 (0.11) |
| Hyperlipidemia | 1 (0.03) |
Notes: ADRs are coded with the preferred terms of MedDRA/J (version 18.1). The figure beside each category of disease shows the number (%) of patients with the type of ADR, while the number of each ADR shows the number of incidents (in parentheses, the number of incidents over the total number of patients researched).
Abbreviation: ADRs, adverse drug reactions.