Table 4. Number of patients with serious adverse events.
Serious adverse event | Octreotide-LAR (n = 51) | Placebo (n = 49) |
---|---|---|
Overall | 12 (23.5%) | 11 (22.4%) |
Pulmonary embolism | 1 (2.0%) | 0 |
Myocardial infarction | 0 | 1 (2.0%) |
Acute renal failure | 2 (3.9%) | 2 (4.1%) |
Renal cyst rupture or infection | 1 (2.0%) | 3 (6.1%) |
Urinary tract infection | 0 | 1 (2.0%) |
Acute pyelonephritis | 0 | 1 (2.0%) |
Ureteral obstruction due to lithiasis | 0 | 1 (2.0%) |
Sepsis due to Klebsiella pneumoniae | 1 (2.0%) | 0 |
Varicella | 1 (2.0%) | 0 |
Umbilical hernia | 1 (2.0%) | 0 |
Acute pancreatitis | 1 (2.0%) | 0 |
Biliary vomiting | 1 (2.0%) | 0 |
Abdominal pain | 0 | 1 (2.0%) |
Anemia | 1 (2.0%) | 1 (2.0%) |
Fever | 1 (2.0%) | 0 |
Pancreatic enzyme elevation | 0 | 1 (2.0%) |
Hyperammonemia | 1 (2.0%) | 0 |
Acute retinal detachment | 1 (2.0%) | 0 |
Genitourinary prolapse | 1 (2.0%) | 0 |
Cystocele | 1 (2.0%) | 0 |
Menometrorrhagia | 1 (2.0%) | 0 |
Data are n (%).
octreotide-LAR, octreotide long-acting release.