Incidence of adverse events (AEs), serious AEs, treatment related AEs, AEs leading to withdrawal

IGF-1 is a hormone that manages the effects of growth hormone (GH) in the body. Percent change from Baseline in IGF-1 levels was measured at Day 141. Baseline was defined as the last non-missing value prior to the first administration of Study Drug (ISIS 766720 or placebo). A negative percent change from Baseline indicated improvement. To perform a meaningful assessment of the pharmacodynamic (PD) activity of ISIS 766720, the lower dose groups (60 mg and 80 mg) and higher dose groups (120 mg and 160 mg) were combined to achieve group size of 7 or more for PD assessments and these were designated as low-dose and high-dose groups respectively.

A TEAE was defined as an adverse event that occurred after the initiation of study drug dosing and before the end of the follow-up period.

Vitals signs included blood pressure, heart rate, respiratory rate, and temperature recorded throughout the study. Clinical significance was determined by the investigator.

Physical examination included weight and body mass index (BMI) recorded throughout the study. Clinical significance was determined by the investigator.

Clinical laboratory assessments included clinical chemistry, hematology, and urinalysis. Clinically-significant abnormal laboratory values were reported as TEAEs if the results may, in the opinion of the Investigator, constitute or be associated with an AE.

ECG assessments included QT, QRS duration, PR interval, ventricular rate, QTcB, QTcF.