Table 3.

Adverse Events and Selected Laboratory Data.^*

Adverse Event or Laboratory Variable	Low-Dose Methotrexate (N = 2391)		Placebo (N = 2395)		P Value
	no. of patients	incidence rate/100 person-yr	no. of patients	incidence rate/100 person-yr
Adverse event
Any event	1488	62.4	1399	56.0	0.004
Serious event	569	13.5	549	13.0	0.52
Infection or infestation
Any event	659	16.5	584	14.4	0.02
Serious event	111	2.24	121	2.47	0.50
Gastrointestinal disorder
Any event	350	7.79	284	6.23	0.006
Serious event	60	1.20	46	0.92	0.22
Neurologic disorder
Any event	213	4.53	195	4.12	0.37
Serious event	53	1.06	55	1.11	0.89
Hemorrhage†
Any event	132	2.71	111	2.28	0.20
Serious event	32	0.63	25	0.50	0.44
Cancer
Reported in case-report forms from visits
Any cancer	52	1.03	30	0.60	0.02
Non–basal-cell skin cancer	31	0.61	10	0.20	0.002
Determined on the basis of a MedDRA query, case-report forms from visits, and adverse-event reports
Any cancer	106	2.15	95	1.93	0.51
Non–basal-cell skin cancer	33	0.65	12	0.24	0.003
Mouth sores or oral pain‡	96	1.95	56	1.13	0.001
Unintended weight loss‡	104	2.10	73	1.47	0.02
Alanine aminotransferase >3x normal range	49	0.97	17	0.34	<0.001
Aspartate aminotransferase >3x normal range	39	0.77	21	0.42	0.03
Leukopenia§	241	5.14	172	3.63	<0.001

^*Serious adverse events were those that resulted in death, were life-threatening, led to hospitalization or prolongation of hospitalization, caused clinically significant incapacity, or were deemed to be an important medical event as judged by the investigator.

^†Data are determined on the basis of a standardized Medical Dictionary for Regulatory Activities (MedDRA) query.

^‡Data are from an explicit question on case-report forms from visits and from adverse-event reports.

^§Data are from results from laboratory assays and from adverse-event reports.