Table 3.
Adverse events (safety analysis set)
| Side effects and adverse events | No. of patients (%) | |||
|---|---|---|---|---|
| LC, n=78 | SO, n=78 | Standard, n=78 | Strict, n=78 | |
| Any side effects | 8 (10.3) | 17 (21.8) | 17 (21.8) | 8 (10.3) |
| Diarrhea | 5 (6.4) | 9 (11.5) | 10 (12.8) | 4 (5.1) |
| Constipation | 1 (1.3) | 3 (3.8) | 2 (2.6) | 2 (2.6) |
| Vomiting | 3 (3.8) | 0 | 3 (3.8) | 0 |
| Abdominal distention | 0 | 2 (2.6) | 2 (2.6) | 0 |
| Any serious adverse events | 14 (17.9) | 17 (21.8) | 15 (19.2) | 16 (20.5) |
| Coronary artery diseases | 3 (3.8) | 4 (5.1) | 3 (3.8) | 4 (5.1) |
| Cerebral infarction | 1 (1.3) | 1 (1.3) | 2 (2.6) | 0 |
| Shunt disorder | 1 (1.3) | 2 (2.6) | 1 (1.3) | 2 (2.6) |
| Aortic valve stenosis | 0 | 1 (1.3) | 0 | 1 (1.3) |
| Arthritis | 1 (1.3) | 0 | 1 (1.3) | 0 |
| Arrhythmia | 2 (2.6) | 2 (2.6) | 2 (2.6) | 2 (2.6) |
| Increase of PTH | 0 | 1 (1.3) | 0 | 1 (1.3) |
| Acute heart failure | 1 (1.3) | 0 | 1 (1.3) | 0 |
| Death | 1 (1.3) | 0 | 1 (1.3) | 0 |
| Femoral fracture | 2 (2.6) | 2 (2.6) | 3 (3.8) | 1 (1.3) |
| Spinal canal stenosis | 1 (1.3) | 1 (1.3) | 0 | 2 (2.6) |
| Lymphadenitis | 0 | 1 (1.3) | 0 | 1 (1.3) |
| Lymph node metastasis | 1 (1.3) | 0 | 0 | 1 (1.3) |
| Myelopathy | 1 (1.3) | 0 | 1 (1.3) | 0 |
| Esophageal bleeding | 0 | 1 (1.3) | 1 (1.3) | 0 |
| Pneumonia | 0 | 1 (1.3) | 1 (1.3) | 1 (1.3) |
| Colon polyp | 1 (1.3) | 0 | 1 (1.3) | 0 |
| Hypotension | 0 | 1 (1.3) | 1 (1.3) | 0 |