Table 3

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

NNCumulative dose of MTX until first eventCumulative dose of MTX until first eventDose of MTX before first eventDose of MTX before first event
I-group*C-group*I-groupC-groupp ValueI-groupC-groupp Value
Gastrointestinal symptoms
 All patients9975400±479 (185)504±495 (330)0.04616.6±7.313.3±6.10.002
 Completers6262434±538 (188)547±524 (343)0.05116.3±7.113.8±6.20.039
Mucocutaneous
 All patients8056589±631 (362)508±548 (275)0.87017.7±7.913.6±7.50.003
 Completers5045592±648 (343)551±578 (286)0.80018.3±8.414.4±7.80.022
CNS
 All patients8854647±676 (345)507±547 (282)0.91116.5±8.012.3±5.6<0.001
 Completers5344773±722 (530)563±588 (312)0.34117.5±7.912.4±5.4<0.001
Renal
 All patients5862509±545 (267)449±461 (266)0.75915.7±8.312.0±5.20.004
 Completers3951590±592 (281)504±475 (300)1.00015.7±8.112.6±5.40.042
Hepatic
 All patients8249536±513 (299)668±517 (540)0.15419.5±7.514.8±6.0<0.001
 Completers5347614±571 (413)662±524 (540)0.66619.9±7.514.7±6.0<0.001
Haematological
 All patients3815618±686 (284)600±589 (315)0.64315.4±8.514.3±6.70.667
 Completers2514758±752 (393)636±593 (406)0.89716.2±8.514.8±6.70.604
General
 All patients4021796±645 (696)631±538 (498)0.47618.5±8.414.2±6.70.046
 Completers2017927±673 (736)725±554 (705)0.47818.8±7.915.3±7.00.171
  • 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.