Table 6.

Abnormal laboratory findings (following Mrowietz et al.⁶⁴) among the different treatment groups at some point during treatment duration

	FAE monotherapy	FAEs + phototherapy	FAEs + MTX	All	P‐valuea
Patients initiating FAE therapy, N	626	123	110	859
Blood parameters, n (% of N )
Leucocytes <3000/μL	29 (4.6)	5 (4.1)	3 (2.7)	37 (4.3)	0.66
Lymphocytes <500/μL (CTCAE grade 3 and 4)	105 (16.8)	21 (17.1)	14 (12.7)	140 (16.3)	0.55
Eosinophils >450/μL (25% above normal upper limit)	102 (16.3)	20 (16.3)	18 (16.4)	140 (16.3)	0.99
Platelets <150 000/μL	48 (7.7)	12 (9.8)	14 (12.7)	74 (8.6)	0.19
Serum parameters, n (% of N )
SGOT >150 IU/L (3 times the normal upper limit)	4 (0.6)	0	0	4 (0.5)	0.47
SGPT >150 IU/L (3 times the normal upper limit)	6 (1.0)	3 (2.4)	5 (4.5)	14 (1.6)	0.02
GGT >213 IU/L (3 times the normal upper limit)	19 (3.0)	1 (0.8)	4 (3.6)	24 (2.8)	0.33
Creatinine >1.20 mg/dL	75 (12.0)	21 (17.1)	21 (19.1)	117 (13.6)	0.06
Urinalysis, n (% of N )
Proteinuria (dipstick urinalysis positive and 24‐hurine collection >0.14 g protein)	79 (12.6)	24 (19.5)	12 (10.9)	115 (13.4)	0.09

^a P‐value derived from chi‐square test.

FAEs, fumaric acid esters; phototherapy, ultraviolet A, ultraviolet B or psoralen + ultraviolet A; MTX, methotrexate; SGOT, serum glutamic oxaloacetic transaminase; SGPT, serum glutamate pyruvate transaminase; GGT, gamma‐glutamyltransferase; CTCAE, Common Terminology Criteria for Adverse Events (available at: http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf; last accessed 30 December 2017). Normal ranges: leucocytes = 4600−9500/μL, lymphocytes = 1000−4050/μL, eosinophils = 40−360/μL, platelets = 150 000−400 000/μL, SGOT = 10−50 IU/L, SGPT = 10−50 IU/L, GGT = 10−71 IU/L, serum creatinine = 0.70−1.20 mg/dL, dipstick urinalysis = negative, 24‐h urine collection ≤0.14 g protein.