Adverse events occurring in ≥20% of patients in either treatment group in the extension study population from randomization to month 11 postrandomization and from months 11 to 35, n (%)
| Randomization to month 11 (extension study population) | Months 11–35 (extension study population) | |||||
|---|---|---|---|---|---|---|
| CNI-free (n = 41) | CNI (n = 40) | p-Value | CNI-free (n = 41) | CNI (n = 40) | p-Value | |
| Blood and lymphatic system disorders | ||||||
| Anemia | 9 (22.0) | 5 (12.5) | 0.379 | 2 (4.9) | 2 (5.0) | 1.000 |
| Gastrointestinal disorders | ||||||
| Diarrhea | 12 (29.3) | 7 (17.5) | 0.295 | 10 (24.4) | 4 (10.0) | 0.140 |
| Nausea | 3 (7.3) | 9 (22.5) | 0.067 | 0 | 0 | – |
| General disorders and administration site conditions | ||||||
| Peripheral edema | 11 (26.8) | 5 (12.5) | 0.162 | 9 (22.0) | 2 (5.0) | 0.048 |
| Infections | ||||||
| Nasopharyngitis | 9 (22.0) | 9 (22.5) | 1.000 | 6 (14.6) | 7 (17.5) | 0.770 |
| Injury, poisoning and procedural complications | ||||||
| Incisional hernia | 10 (24.4) | 7 (17.5) | 0.587 | 10 (24.4) | 6 (15.0) | 0.404 |
| Investigations | ||||||
| Increased hepatic enzyme | 10 (24.4) | 4 (10.0) | 0.140 | 1 (2.4) | 2 (5.0) | 0.616 |
| Metabolism and nutrition disorders | ||||||
| Hypercholesterolemia | 13 (31.7) | 3 (7.5) | 0.011 | 4 (9.8) | 1 (2.5) | 0.359 |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 5 (12.2) | 8 (20.0) | 0.379 | 2 (4.9) | 2 (5.0) | 1.000 |
| Back pain | 6 (14.6) | 10 (25.0) | 0.276 | 9 (22.0) | 1 (2.5) | 0.014 |
| Skin and subcutaneous tissue disorders | ||||||
| Pruritus | 9 (22.0) | 6 (15.0) | 0.569 | 5 (12.2) | 4 (10.0) | 1.000 |
| Vascular disorders | ||||||
| Hypertension | 9 (22.0) | 6 (15.0) | 0.569 | 5 (12.2) | 5 (12.5) | 1.000 |
Table 1Fishers’ exact test (between-group comparison).
CNI, calcineurin inhibitor.