Safety and tolerability
Hyperglycemia, death, multi-organ dysfunction, hyperglycemia, hyperglycemia-related AEs, deaths
HYPERGLYCEMIA, UNCONTROLLED HYPERTENSION, ADVERSE EVENTS, HYPERGLYCEMIA, ADVERSE EVENT, SYNDROME
Median duration of exposure to pasireotide was 35.0 weeks (range 0−;268), with a median dose of 1.53 mg/day (range 0.29−;1.80). Median duration of exposure to cabergoline was 16.9 weeks (range 1−;215), with a median dose of 0.50 mg/day (range 0.44−;0.97).All patients (N=68) reported at least one AE and 28/68 (41.2%) patients had a grade 3/4 AE (Summary of adverse events (≥10%), overall and by treatment regimen.*Excluding hematological and biological AEs.
Hyperglycemia is self-monitored fasting blood glucose value of >130 mg/dL AE, adverse event; GGT, gamma-glutamyl transferase.The most common AEs leading to discontinuation were increased gamma-glutamyl transferase (GGT) and hyperglycemia (two patients each, 2.9%). Twenty-three (33.8%) patients had ≥1 AE leading to dose adjustment or interruption. Details on special safety assessments such as hyperglycemia-related AEs, blood glucose, HbA1c, IGF-1 as well as hematological and biochemical abnormalities are presented in the Three (4.4%) patients died during the study, two (2.9%) during the core phase and one (1.5%) during the extension. All deaths were considered unrelated to study medication. The causes during the core phase were multi-organ dysfunction syndrome for one patient aged 79 years and unknown for the other aged 34 years. Uncontrolled hypertension was reported as the cause of death for the patient aged 47 during the extension phase.