Table 2.

Summary of Leflunomide-Related Adverse Events, CTCAE v4.03

	Leflunomide: 20 mg n=3		Leflunomide: 40 mg n=3		Leflunomide: 60 mg n=6
Adverse Event^	Any Grade	Grade ≥ 3	Any Grade	Grade ≥ 3	Any Grade	Grade ≥ 3
Hematologic
Anemia	0	0	1	1	1	1
Leukopenia	2	0	1	0	1	0
Lymphopenia	0	0	1	1	1	1
Neutropenia	2	0	1	0	1	0
Thrombocytopenia	1	0	1	0	1	0
Non-Hematologic
Abdominal pain	0	0	0	0	1	0
Back pain	1	0	0	0	0	0
Diarrhea	0	0	0	0	1	0
Edema	0	0	0	0	1	0
Fatigue	0	0	1	0	2	0
Headache	1	0	0	0	0	0
Hypertension	1	0	0	0	0	0
Hypoalbuminemia	0	0	1	0	0	0
Increased AST	0	0	0	0	1	1*
Increased blood bilirubin	0	0	0	0	1	0
Lung infection	0	0	0	0	1	1

^{^}: Includes adverse events with an attribution of at least possibly related to leflunomide, worst grade during cycle 1.

^*: classified as dose limiting

Abbreviations: AST: aspartate aminotransferase; CTCAE: Common Terminology Criteria for Adverse Events