Table 3.
Summary of serious adverse events and potentially drug-related adverse events reported in any treatment group (SAF).
| Proportion of patients, n (%) | Tacrolimus (n = 45) |
Placebo (n = 38) |
|---|---|---|
| Patients with any adverse event | 36 (80.0) | 31 (81.6) |
| Patients with any serious adverse event* | 5 (11.1) | 6 (15.8) |
| Myasthenia gravis | 3 (6.7) | 4 (10.5) |
| Lung infection | 1 (2.2) | 1 (2.6) |
| Diabetes mellitus | 1 (2.2) | (0.0) |
| Dyspnoea | 1 (2.2) | (0.0) |
| Bronchitis | 0 (0.0) | 2 (5.3) |
| Atrial fibrillation | 0 (0.0) | 1 (2.6) |
| Patients with any potentially drug-related adverse event | 33 (73.3) | 29 (76.3) |
| Reported in >5% in any treatment group* | ||
| Upper respiratory tract infection | 9 (20.0) | 6 (15.8) |
| Myasthenia gravis | 7 (15.6) | 6 (15.8) |
| Nasopharyngitis | 6 (13.3) | 5 (13.2) |
| Diarrhoea | 3 (6.7) | 6 (15.8) |
| Hypertension | 0 (0.0) | 5 (13.2) |
| Bronchitis | 0 (0.0) | 4 (10.5) |
| Urinary tract infection | 3 (6.7) | 1 (2.6) |
| Diabetes mellitus | 3 (6.7) | 0 (0.0) |
| Blood lactate dehydrogenase increased | 0 (0.0) | 2 (5.3) |
| Insomnia | 0 (0.0) | 2 (5.3) |
| Sleep disorder | 0 (0.0) | 2 (5.3) |
There was no significant difference between treatment groups in the number of patients who reported at least one adverse event (p = 1.000; Fisher’s exact test), at least one serious adverse event (p = 0.747; Fisher’s exact test) or at least one potentially drug-related adverse event (p = 0.804; Fisher’s exact test). * If a patient experienced more than one episode of an adverse event, the patient was counted only once within a preferred term.
SAF, safety analysis set.