Data analyses
stoma, Crohn’s disease
ADVERSE EVENTS
The intent-to-treat (ITT) population consisted of patients who enrolled and were eligible at baseline (i.e., after PS optimization and stabilization) to receive teduglutide. Efficacy analyses were based on the ITT population, all of whom received teduglutide. The safety population comprised all patients in the ITT population who received ≥ 1 dose of teduglutide and the PK population included all patients in the safety analysis population for whom PK data were sufficient and interpretable. In these studies, the ITT population was the same as the safety population. Treatment compliance was defined as patients receiving ≥ 80% of the planned study drug doses, assessed by site investigators counting used/unused vials at every clinic visit.Efficacy endpoints were defined in an analogous manner to previous pivotal studies [Efficacy was evaluated between baseline and 24 weeks in TED-C14-004 and SHP633-306 and between baseline and 30 months in TED-C14-004. Among patients who entered SHP633-307, the total follow-up periods, including the prior studies, were up to 14–57 months of total teduglutide exposure for patients from SHP633-306 and TED-C14-004.Post hoc analyses of PS volume reductions in patients with Crohn’s disease, with and without a stoma, were performed for TED-C14-004.Single-dose PK parameters were estimated using a non-compartmental analysis and included the maximum plasma concentration of teduglutide (CSafety analyses included the monitoring of adverse events (AEs), body weight, BMI, vital signs, 12-lead electrocardiogram (ECG), serum biochemistry, hematology, and presence of antibodies to teduglutide. AEs were coded using the Medical Dictionary for Regulatory Activities versions 17.1 (TED-C14-004) and 21.0 (SHP633-306 and SHP633-307) [