Table 4. AE ≥ grade 3 and hospitalisation.
| Cohort 1: Capecitabinea | Cohort 2: 5-FU | |||||||
|---|---|---|---|---|---|---|---|---|
| Overall (243) | PPI (50) | Non-PPI (193) | p value | Overall (196) | PPI (52) | Non-PPI (144) | p value | |
| All | 39.5% | 48.0% | 37.3% | 0.19 | 29.1% | 40.4% | 25.0% | 0.049 |
| Diarrhoea | 21.4% | 32.0% | 18.7% | 0.05 | 12.8% | 23.1% | 9.0% | 0.01 |
| HFS | 16.0% | 22.0% | 14.5% | 0.20 | 0 | 0 | 0 | - |
| Infection | 2.9% | 8.0% | 1.6% | 0.03 | 4.6% | 1.9% | 5.6% | 0.01 |
| Rectitis | 6.6% | 6.0% | 6.7% | 1.00 | 8.7% | 11.5% | 7.6% | 0.71 |
| Cystitis | 18.1% | 24.0% | 16.6% | 0.22 | 0.5% | 0 | 0.7% | 0.34 |
| Oral mucositis | 6.2% | 8.0% | 5.7% | 0.52 | 9.7% | 11.5% | 9.0% | 0.69 |
| Other | 2.5% | 2.0% | 2.6% | 1.00 | 5.6% | 7.7% | 4.9% | 1.00 |
| Hospitalisation Days (median) |
6.1% 2 (1–22) |
8.0% 1.5 (1–22) |
5.6% 2 (1–16) |
0.51 1.00 |
9.2% 7 (2–25) |
13.5% 7 (2–12) |
7.6% 7 (3–25) |
0.26 0.48 |
| ICU | 1.2% | 2.0% | 1.0% | 0.50 | 1.5% | 3.8% | 0.7% | 0.17 |
a
Missing data of 8 of 251 patients
PPI: proton-pump inhibitors; HFS: hand and foot syndrome; ICU: Intensive care unit
The bold values represent statistical significant differences in the occurrence of AE>= grade 3 and hospitalization between PPI and non-PPI groups