Table 2.

Summary of reasons for premature withdrawal from treatment (intention-to-treat population)

ParameterMMF (n = 185; n [%])IVC (n = 185; n [%])
Completed 24-wk open-label induction phase150 (81.1)156 (84.3)
Total no. of patients withdrawn prematurely35 (18.9)29 (15.7)
Reasons for withdrawal from induction phase
    adverse event21 (60.0)12 (41.4)
    deterioration with respect to serum creatinine after 12 and 16 wk of treatment0 (0.0)2 (6.9)
    dosage reduction of MMF <2 g/d for >14 d1 (2.9)0 (0.0)
    lost to follow-up1 (2.9)2 (6.9)
    patient died3 (8.6)1 (3.4)
    patient withdrew consent6 (17.1)5 (17.2)
    physician decision1 (2.9)3 (10.3)
    sponsor decision2 (5.7)1 (3.4)
    noncompliance0 (0.0)1 (3.4)
    reason not noted0 (0.0)2 (6.9)