Table 2.
Patient demographics
| Baseline characteristic | Safety analysis set (N = 3085) | ILD patientsa (N = 39) | ||
|---|---|---|---|---|
| n | % | n | % | |
| Gender | ||||
| Male | 1965 | 63.7 | 32 | 1.6 |
| Female | 1120 | 36.3 | 7 | 0.6 |
| Age | ||||
| <65 years | 1524 | 49.4 | 13 | 0.9 |
| 65–74 years | 1058 | 34.3 | 16 | 1.5 |
| ≥75 years | 503 | 16.3 | 10 | 2.0 |
| Median (range) | 65.0 (18–90) | – | 69.0 (40–90) | |
| KRAS status | ||||
| Wild | 3003 | 97.3 | 37 | 1.2 |
| Mutant | 3 | 0.1 | 1 | 33.3 |
| Not determinable | 79 | 2.6 | 1 | 1.3 |
| ECOG PS | ||||
| 0 | 1877 | 60.8 | 23 | 1.2 |
| 1 | 942 | 30.5 | 10 | 1.1 |
| 2 | 241 | 7.8 | 5 | 2.1 |
| 3 | 22 | 0.7 | 1 | 4.5 |
| 4 | 3 | 0.1 | 0 | 0.0 |
| Treatment lines | ||||
| First line | 310 | 10.1 | 11 | 3.5 |
| Second line | 543 | 17.6 | 8 | 1.5 |
| Third line or later | 2232 | 72.4 | 20 | 0.9 |
| Past treatment regimens | ||||
| No | 173 | 5.6 | 8 | 4.6 |
| Yes (duplicate counting) | 2911 | 94.4 | 31 | 1.1 |
| FOLFOX | 2439 | 79.1 | 25 | 1.0 |
| FOLFIRI | 1907 | 61.8 | 20 | 1.0 |
| Bevacizumab | 2113 | 68.5 | 23 | 1.1 |
| Cetuximab | 917 | 29.7 | 9 | 1.0 |
| Others | 2067 | 67.0 | 23 | 1.1 |
| Unknown | 1 | 0.0 | 0 | 0 |
| Treatment regimen | ||||
| Monotherapy | 1254 | 40.7 | 16 | 1.3 |
| Chemotherapy (duplicate counting) | 1831 | 59.4 | 23 | 1.3 |
| FOLFOX | 573 | 18.6 | 13 | 2.3 |
| FOLFIRI | 1045 | 33.9 | 13 | 1.2 |
| CPT-11 | 277 | 9.0 | 0 | 0.0 |
| Others | 191 | 6.2 | 1 | 0.5 |
| Smoking history | ||||
| No | 1365 | 44.3 | 14 | 1.0 |
| Yes | 947 | 30.7 | 19 | 2.0 |
| Current smoking | 234 | 7.6 | 5 | 2.1 |
| Smoked in the past | 713 | 23.1 | 14 | 2.0 |
| Unknown | 773 | 25.1 | 6 | 0.8 |
| Previous or concurrent ILD | ||||
| No | 3051 | 98.9 | 34 | 1.1 |
| Yes (reported by physicians) | 34 | 1.1 | 5 | 14.7 |
ECOG PS Eastern Cooperative Oncology Group Performance Status, ILD interstitial lung disease
aDetected by the ILD review subcommittee