Table 3.
Treatment-emergent AEs with the preferred term occurring in ≥5% of patients in either treatment group
| System Organ Class | Tacrolimus and Low-Dose Steroid (n=67) | High-Dose Steroid (n=69) |
|---|---|---|
| Gastrointestinal disordersa | 16 (23.9) | 12 (17.4) |
| Abdominal pain | 7 (10.4) | 2 (2.9) |
| Abdominal pain upper | 4 (6.0) | 2 (2.9) |
| Diarrhea | 8 (11.9) | 1 (1.5) |
| Dyspepsia | 2 (3.0) | 8 (11.6) |
| General disorders and administration-site conditions | 9 (13.4) | 11 (15.9) |
| Face edema | 1 (1.5) | 5 (7.2) |
| Generalized edema | 4 (6.0) | 0 |
| Edema | 4 (6.0) | 7 (10.1) |
| Infections and infestationsb | 7 (10.4) | 11 (15.9) |
| Nasopharyngitis | 7 (10.4) | 11 (15.9) |
| Investigations | 1 (1.5) | 4 (5.8) |
| ALT increased | 1 (1.5) | 4 (5.8) |
| Nervous system disorders | 10 (14.9) | 3 (4.3) |
| Headache | 7 (10.4) | 2 (2.9) |
| Paresthesia | 4 (6.0) | 1 (1.5) |
| Respiratory, thoracic, and mediastinal disorders | 4 (6.0) | 4 (5.8) |
| Cough | 4 (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.