Table 3.
Local Complications and SAEs
| Category | No. | % |
|---|---|---|
| Component events for local complications | ||
| Minor morbidity only | 2 | 2.3 |
| Minor and major morbidity | 2 | 2.3 |
| Major morbidity only | 10 | 11.6 |
| Total local complications | 14 | 16.3 |
| Patients without local complication (no morbidity) | 72 | 83.7 |
| Component events for SAEs | ||
| Grade 5, fatal | 8* | 9.3 |
| Grade 4, life threatening | 6 | 7.0 |
| Grade 3, serious | 13 | 15.1 |
| Total SAEs | 27 | 31.4 |
| Patients without SAEs | 59 | 68.6 |
| Total | 86 | 100.0 |
Abbreviation: SAE, serious adverse event.
*
Four were directly related to chemotherapy, four were unrelated (two died within 3 months of completing therapy from postoperative sepsis after curative resection, one from pain and anorexia, one from progressive chronic obstructive pulmonary disease).