Table 3. Comparisons Between Patients With and Without Severe Adverse Events.
| Variable | No. (%) | P value | |
|---|---|---|---|
| With severe AEs | Without severe AEs | ||
| No. | 64 | 143 | |
| Age, mean (SD), y | 72.1 (7.2) | 69.8 (7.6) | .049 |
| Sex | |||
| Male | 51 (80) | 119 (83) | .54 |
| Female | 13 (20) | 24 (17) | |
| Eligibility using criteria 1 | .07 | ||
| Eligible | 35 (55) | 97 (68) | |
| Ineligible | 29 (45) | 46 (32) | |
| Eligibility using criteria 2 | |||
| Eligible | 32 (50) | 84 (59) | .24 |
| Ineligible | 32 (50) | 59 (41) | |
| Reason for ineligibility | |||
| ECOG performance status 2-3 | 11 (17) | 12 (8) | .07 |
| Active metastase | |||
| Criteria 1 | 13 (20) | 26 (18) | .72 |
| Criteria 2 | 5 (8) | 10 (7) | .83 |
| Abnormal laboratory findings | 9 (14) | 9 (6) | .07 |
| Comorbidity | 14 (22) | 26 (18) | .54 |
Abbreviations: AEs, adverse events; ECOG, Eastern Cooperative Oncology Group.