Table 4.

Adverse events during the trial

Variable	High-GFR Arm		Low-GFR Arm
	Supportive Care, n=54	Corticosteroid Monotherapy, n=55	Supportive Care, n=26	Immunosuppressive Combination, n=27
Patients with at least one SAE	14	12	6	17
Total no. of SAEs	19	14	9	19
Total no. of infectious events	69	115	48	59
Total no. of infectious SAEs	2	4	1	4
Death	1a	0	0	1b
Additional side effects of interestc
Increase of liver enzymes (i.e., ALT>50 IU/ml)	10	8	2	5
Leukopenia (i.e., leukocyte count <4000/ml)	3	1	0	1
Malignancy	0	0	0	2
Impaired glucose tolerance/diabetes mellitus	1	9	1	1
Gastrointestinal bleeding	0	0	0	0
Fracture	0	1	0	0
Osteonecrosis	0	0	0	0
Body weight gain (≥5 kg within the first year)	3	9	2	5
Body weight gain (≥5 kg during the trial phase)	10	13	5	6
Body weight gain (≥10 kg during the trial phase)	2	3	3	2

ALT, alanine transaminase.

^aOne patient died in a motor vehicle accident.

^bOne patient died of pneumogenic sepsis.

^cNumber of patients with at least one event.