Table 1.
Distribution of women in Italian tamoxifen chemoprevention trial according to alanine aminotransferase concentrations and hepatitis B or C virus profile
| Results | Total (n=5408) | Placebo (n=2708) | Tamoxifen (n=2700) | P value* |
|---|---|---|---|---|
| High ALT at baseline (>ULN): | 321 (5.9%) | 161 (5.9%) | 160 (5.9%) | |
| Normal ALT during follow up | 223 | 114 | 109 | Reference |
| Single elevation of ALT during follow up (≥1.5×ULN) | 52 | 29 | 23 | 0.644 |
| Multiple elevations of ALT during follow up (≥1.5×ULN) | 46 | 18 | 28 | 0.148 |
| Normal ALT at baseline: | 5087 | 2547 | 2540 | |
| Normal ALT during follow up | 4853 | 2433 | 2420 | Reference |
| Single elevation of ALT during follow up (≥1.5×ULN) | 170 | 92 | 78 | 0.312 |
| Multiple elevations of ALT during follow up (≥1.5×ULN) | 64 | 22 | 42 | 0.016 |
| Positive for hepatitis B/C virus or antinuclear antibody | 12 | 4 | 8 | 0.265 |
| Possible non-alcoholic fatty liver disease | 52 | 18 | 34 | 0.036 |
ALT=alanine aminotransferase; ULN=upper limit of normal.
*
Fisher's exact test.