Cumulative dose of methotrexate (MTX) until the first recorded adverse event and dose of MTX in the month before the first recorded event for each of the seven main predefined categories of adverse events
| N | N | Cumulative dose of MTX until first event | Cumulative dose of MTX until first event | Dose of MTX before first event | Dose of MTX before first event | |||
|---|---|---|---|---|---|---|---|---|
| I-group* | C-group* | I-group | C-group | p Value | I-group | C-group | p Value | |
| Gastrointestinal symptoms | ||||||||
| All patients | 99 | 75 | 400±479 (185) | 504±495 (330) | 0.046 | 16.6±7.3 | 13.3±6.1 | 0.002 |
| Completers | 62 | 62 | 434±538 (188) | 547±524 (343) | 0.051 | 16.3±7.1 | 13.8±6.2 | 0.039 |
| Mucocutaneous | ||||||||
| All patients | 80 | 56 | 589±631 (362) | 508±548 (275) | 0.870 | 17.7±7.9 | 13.6±7.5 | 0.003 |
| Completers | 50 | 45 | 592±648 (343) | 551±578 (286) | 0.800 | 18.3±8.4 | 14.4±7.8 | 0.022 |
| CNS | ||||||||
| All patients | 88 | 54 | 647±676 (345) | 507±547 (282) | 0.911 | 16.5±8.0 | 12.3±5.6 | <0.001 |
| Completers | 53 | 44 | 773±722 (530) | 563±588 (312) | 0.341 | 17.5±7.9 | 12.4±5.4 | <0.001 |
| Renal | ||||||||
| All patients | 58 | 62 | 509±545 (267) | 449±461 (266) | 0.759 | 15.7±8.3 | 12.0±5.2 | 0.004 |
| Completers | 39 | 51 | 590±592 (281) | 504±475 (300) | 1.000 | 15.7±8.1 | 12.6±5.4 | 0.042 |
| Hepatic | ||||||||
| All patients | 82 | 49 | 536±513 (299) | 668±517 (540) | 0.154 | 19.5±7.5 | 14.8±6.0 | <0.001 |
| Completers | 53 | 47 | 614±571 (413) | 662±524 (540) | 0.666 | 19.9±7.5 | 14.7±6.0 | <0.001 |
| Haematological | ||||||||
| All patients | 38 | 15 | 618±686 (284) | 600±589 (315) | 0.643 | 15.4±8.5 | 14.3±6.7 | 0.667 |
| Completers | 25 | 14 | 758±752 (393) | 636±593 (406) | 0.897 | 16.2±8.5 | 14.8±6.7 | 0.604 |
| General | ||||||||
| All patients | 40 | 21 | 796±645 (696) | 631±538 (498) | 0.476 | 18.5±8.4 | 14.2±6.7 | 0.046 |
| Completers | 20 | 17 | 927±673 (736) | 725±554 (705) | 0.478 | 18.8±7.9 | 15.3±7.0 | 0.171 |
Values are mean±SD (median).
C-group, conventional treatment strategy group; I-group, intensive treatment strategy group.
CNS, central nervous system; N, number of patients with available data.