Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC)

Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE)

Time frame · Day 1 up to approximately 55 weeks

A TEAE was any unfavorable and unintended sign, symptom, or disease temporally associated with apraglutide, whether or not related, that occurred or worsened after the dose of apraglutide. A serious TEAE was defined as any TEAE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. Clinically significant changes from baseline in clinical chemistry, hematology, hemostasis, anti-drug antibodies (ADAs), and urine analysis were reported as adverse events. Adverse events of special interest (AESI) included injection site reaction, gastrointestinal obstruction, gallbladder, biliary, and pancreatic disease, fluid overload, colorectal polyps, malignancies.

Absolute Change in Absorption of Energy Over Metabolic Balance (MB) Periods From Baseline at Week 48

Time frame · Baseline and Week 48

Applicable to Protocol V3.0 implemented in France (classed as secondary endpoint in Protocol V4.0 \[implemented in Belgium\]). The absorption was defined as dietary intake minus output from fecal excretion over a 72-hour MB period at a given analysis time point. Since dietary intake and fecal excretion were measured daily, i.e., up to three measurements may contribute to absorption calculations, the average over all available daily absorption measurements over the 72-hour period were used for analysis.

Relative Change From Baseline in Actual Weekly Parenteral Support (PS) Volume at Weeks 4, 24, and 52

Time frame · Baseline, Week 4, Week 24, and Week 52

The sum of daily PS volume (including extra fluids) from weekly PS diary data recorded for the corresponding analysis timepoint was used for analysis.

Absolute Change From Baseline in Actual Weekly PS Volume at Weeks 24 and 52

Time frame · Baseline, Week 24 and Week 52

The sum of daily PS volume (including extra fluids) from weekly PS diary data recorded for the corresponding analysis timepoint was used for analysis.

Number of Participants Who Achieved a Reduction of at Least 1 Day Per Week of PS From Baseline at Weeks 24 and 52

Time frame · Baseline, Week 24 and Week 52

Participants were considered to have a reduction of at least one day per week of PS from Baseline (incl. extra fluids) if the number of days with PS from weekly PS diary data recorded for the corresponding analysis timepoint was smaller compared to the number of days with PS from weekly PS diary data for Baseline.

Number of Participants Considered Clinical Responders at Weeks 24 and 52

Time frame · Baseline, Week 24 and 52

Clinical response was defined as a 20% reduction of PS volume from Baseline. The sum of daily PS volume (including extra fluids) from weekly PS diary data recorded for the corresponding analysis timepoint was used for analysis.

Number of Participants Who Achieved Enteral Autonomy at Weeks 24 and 52

Time frame · Weeks 24 and 52

Enteral autonomy was defined as a participant not receiving PS for hydration or parenteral nutrition (PN) for calories. Participants may have still receive minimal fluid to maintain patency of the central line or for specific elemental/micro-nutrient needs (e.g., \<100 mL fluid for administration of magnesium).

Absolute Change in Total Energy in PN From Baseline at Weeks 24 and 52

Time frame · Baseline, Week 24 and Week 52

PN was defined as PS that includes protein, carbohydrate, fat, vitamins, and/or trace elements.

Relative Change in Absorption of Energy Over MB Periods From Baseline at Week 48

Time frame · Baseline and Week 48

The absorption was defined as dietary intake minus output from fecal excretion over a 72-hour MB period at a given analysis time point. Since dietary intake and fecal excretion were measured daily, i.e., up to three measurements may contribute to absorption calculations, the average over all available daily absorption measurements over the 72-hour period were used for analysis.

Absolute Change in Absorption of Macronutrients Over MB Periods From Baseline at Weeks 4 and 48

Time frame · Baseline, Week 4 and Week 48

The absorption was defined as dietary intake minus output from fecal excretion over a 72-hour MB period at a given analysis time point. Since dietary intake and fecal excretion were measured daily, i.e., up to three measurements may contribute to absorption calculations, the average over all available daily absorption measurements over the 72-hour period were used for analysis.

Absolute Change in Urine Volume Over MB Periods From Baseline at Week 4 and Week 48

Time frame · Baseline, Week 4 and Week 48

Based on average daily urine volume data derived as per balance period calculations.

Absolute Change in Absorption of Energy Over MB Periods From Baseline at Week 4

Time frame · Baseline and Week 4

The absorption was defined as dietary intake minus output from fecal excretion over a 72-hour MB period at a given analysis time point. Since dietary intake and fecal excretion were measured daily, i.e., up to three measurements may contribute to absorption calculations, the average over all available daily absorption measurements over the 72-hour period were used for analysis.