Table 5.
Signal detection for 5-FU- and capecitabine-associated stomatitis.
| N | PRR (χ2) |
ROR (95% two-sided CI) |
IC (95% two-sided CI) |
EBGM (95% one-sided CI) |
||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 5-FU | 193 | 5.905 * (779.160) |
5.959 * (5.169, 6.748) |
2.517 * (2.312, 2.722) |
5.853 * (5.184) |
|||||
| Capecitabine | 174 | 6.141 * (741.267) |
6.192 * (5.331, 7.053) |
2.567 * (2.351, 2.782) |
6.087 * (5.357) |
Colum headings are identical to Table 3.
*: signal detected, and a signal means a drug-associated adverse event (see “Methods” for the criteria of detection).
Stomatitis was coded as PT10042128.