TABLE 5.

Number of Patients with Rejection, Depression, Anemia, Neutropenia, and Clinically Significant Infection by Week 48 (the Safety Population)

Patients Experiencing Safety Parameters Within 48 Weeks	Prophylaxis Arm (n = 54)	Observation Arm: No Treatment (n = 46)	Observation Arm: Switched to Treatment (n = 14)
Patients with at least 1 endpoint, n (%)*	33 (61.1)	16 (34.8)	12 (85.7)
Patients with biopsy-proven rejection, n (%)	3 (5.6)	3 (6.5)	0
Patients with depression, n (%)	1 (1.9)	1 (2.2)	1 (7.1)
Patients with anemia, n (%)	13 (24.1)	1 (2.2)	5 (35.7)
Patients with grade 3 or 4 neutropenia, n (%)	14 (25.9)	3 (6.5)	8 (57.1)
Patients with clinically significant infections requiring treatment, n (%)	19 (35.2)	9 (19.6)	6 (42.9)

NOTE: For prophylaxis patients and patients switched to the treatment, the weeks are based on the initiation of treatment. For patients who received no treatment, the weeks are based on the day of randomization.

^*At least 1 endpoint of biopsy-proven rejection, depression, anemia, neutropenia, or clinically significant infection.