Table 3. Risk factors associated with tumor bleeding.
| Characteristics | Univariate analysis | |||
|---|---|---|---|---|
| cHR | 95% CI | P* | ||
| Allocated treatment | ||||
| Placebo | 1.00 | - | - | |
| Lansoprazole | 0.67 | 0.21–2.11 | 0.496 | |
| Age (yr) | ||||
| <65 | 1.00 | - | - | |
| ≥65 | 0.47 | 0.06–3.72 | 0.473 | |
| Sex | ||||
| Female | 1.00 | - | - | |
| Male | 1.50 | 0.33–6.74 | 0.599 | |
| Current smoker | 1.15 | 0.32–4.20 | 0.829 | |
| Current alcohol drinking | 0.79 | 0.25–2.55 | 0.697 | |
| Baseline hemoglobin level (g/dL) | ||||
| <10.0 | 1.00 | - | - | |
| ≥10.0 | 0.79 | 0.21–2.95 | 0.726 | |
| ECOG performance status | ||||
| 0 | 1.00 | - | - | |
| 1–2 | 0.24 | 0.04–1.44 | 0.120 | |
| Palliative chemotherapy | ||||
| 1st line | 1.00 | - | - | |
| 2nd line | 0.96 | 0.20–4.65 | 0.964 | |
| Tumor size (cm) | ||||
| <5 | 1.00 | - | - | |
| ≥5† | NA | NA | NA | |
| Tumor location | ||||
| Lower 1/3 | 1.00 | - | - | |
| Middle 1/3 | 0.70 | 0.14–3.53 | 0.664 | |
| Upper 1/3 | 1.51 | 0.28–8.30 | 0.632 | |
| Endoscopic findings of tumor type | ||||
| Borrmann type IV (linitis plastica) | 1.00 | - | - | |
| Borrmann type II/III (ulcerofungating/ulceroinfiltrative mass) | 0.80 | 0.17–3.72 | 0.774 | |
| Tumor histology‡ | ||||
| Differentiated type | 1.00 | - | - | |
| Undifferentiated type | 2.66 | 0.54–12.95 | 0.227 | |
cHR = crude hazard ratio; CI = confidence interval; ECOG = Eastern Cooperative Oncology Group; NA = not applicable.
*Fine-Gray regression model; †cHR could not be estimated because no bleeding events occurred in patients with tumor sizes of less than 5 cm; ‡Differentiated type denotes papillary-, well-, or moderately-differentiated adenocarcinoma, and undifferentiated type denotes poorly differentiated adenocarcinoma or signet ring cell carcinoma.