A Study of Teduglutide (Revestive®) in Children, Teenagers and Adults With Short Bowel Disease

Number of Participants With Adverse Events of Special Interest (AESI)

Time frame · Up to 24 months

AESI will include biliary disorders and cholecystitis; pancreatic disease; cardiovascular adverse events associated with fluid overload; intestinal obstruction; stoma complications; malignancy; gastrointestinal neoplastic growth, including colorectal polys and small bowel neoplasia; adverse events associated with increased absorption of concomitant oral medications; anxiety; injection site reactions and suspected immunogenic reactions (like hypersensitivity or other reactions); embryo-fetal toxicity (assessed through follow up of all pregnancies).

Number of Participants With Adverse Events (AEs)

Time frame · Up to 24 months

An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. A serious adverse events (SAEs) is any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to investigational product or not and at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, congenital abnormality/birth defect, an important medical event. Number of participants with AEs including serious and non-serious AEs will be assessed.

Percentage of Participants With Clinical Response at Week 12 and 24

Time frame · Week 12 and 24

Clinical response will be defined as a 20 percent (%) or more reductions on weekly parenteral support volume.

Change From Baseline in Weekly Parenteral Support Volume at Week 12 and 24

Time frame · Baseline, Week 12 and 24

Parenteral support volume will be assessed at baseline (before treatment), and at Week 12, and 24.

Change From Baseline in Number of Days per Week of Parenteral Support at Week 12 and 24

Time frame · Baseline, Week 12 and 24

Change from baseline in number of days per week requiring parenteral support will be assessed at baseline (before treatment), and at Week 12 and 24.