Table 2.
Number (percentage) of patients with at least one serious or nonserious adverse event over the 1-year follow-up period according to randomization to sirolimus added on to conventional therapy (sirolimus) or conventional therapy only (conventional)
| Adverse Events | Sirolimus, n=21 | Conventional, n=20 |
|---|---|---|
| Serious | ||
| ESRD | 2 (9.5) | 0 |
| Acute diverticulitis | 1 (4.8) | 0 |
| Anal fissures, broncopneumoniaa | 1 (4.8) | 0 |
| Peripheral edemab | 1 (4.8) | 0 |
| Renal cyst rupture | 1 (4.8) | 0 |
| Inguinal hernia, gastroenteritis, pneumoniaa | 0 | 1 (5) |
| Chest pain | 0 | 1 (5) |
| Acute kidney function worsening | 0 | 1 (5) |
| Atrial fibrillation, ventricular extrasystolesa | 0 | 1 (5) |
| Acute bronchitis | 0 | 1 (5) |
| Hematuria | 0 | 1 (5) |
| Nonserious | ||
| Peripheral edema | 18 (85.7) | 11 (55.0)c |
| Aphthous stomatitisb | 14 (66.7) | 0d |
| Upper respiratory tract infections | 14 (66.7) | 6 (30.0)c |
| Acneb | 7 (33.3) | 0c |
| Dyspepsia | 5 (23.8) | 2 (10.0) |
| Diarrheab | 4 (19.0) | 0 |
| Dysmenorrhea | 4 (19.0) | 1 (5.0) |
| Arrhythmias | 4 (19.0) | 4 (20.0) |
| Dermatitis | 3 (14.3) | 1 (5.0) |
| Urinary tract infections | 3 (14.3) | 5 (25.0) |
| Hematuria | 2 (9.5) | 7 (35.0) |
| Angioedemab | 3 (14.3) | 0 |
a
Events observed in the same patient.
b
Treatment-related events according to the investigators’ judgment.
c
P<0.05 versus sirolimus.
d
P<0.001 versus sirolimus.