Table 3.

Treatment-emergent AEs with the preferred term occurring in ≥5% of patients in either treatment group

System Organ ClassTacrolimus and Low-Dose Steroid (n=67)High-Dose Steroid (n=69)
Gastrointestinal disordersa16 (23.9)12 (17.4)
 Abdominal pain7 (10.4)2 (2.9)
 Abdominal pain upper4 (6.0)2 (2.9)
 Diarrhea8 (11.9)1 (1.5)
 Dyspepsia2 (3.0)8 (11.6)
General disorders and administration-site conditions9 (13.4)11 (15.9)
 Face edema1 (1.5)5 (7.2)
 Generalized edema4 (6.0)0
 Edema4 (6.0)7 (10.1)
Infections and infestationsb7 (10.4)11 (15.9)
 Nasopharyngitis7 (10.4)11 (15.9)
Investigations1 (1.5)4 (5.8)
 ALT increased1 (1.5)4 (5.8)
Nervous system disorders10 (14.9)3 (4.3)
 Headache7 (10.4)2 (2.9)
 Paresthesia4 (6.0)1 (1.5)
Respiratory, thoracic, and mediastinal disorders4 (6.0)4 (5.8)
 Cough4 (6.0)4 (5.8)
  • Values expressed as number of patients (%). Patients could have more than one AE. ALT, alanine aminotransferase.

  • a Includes one drug-related serious AE in the tacrolimus and low-dose steroid group.

  • b Includes three drug-related serious AEs; two in the tacrolimus and low-dose steroid group, and one in the high-dose steroid group.