Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome

Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Weight-normalized Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET)

Time frame · Baseline, EOT/ET (up to Week 24)

Number of participants who achieved at least 20% reduction from baseline in weight-normalized PS volume at EOT/ET (up to Week 24) were reported. EOT/ET was defined as the last available visit after the date of first dose (or randomization in standard of care treatment group) during the 24-week treatment period.

Plasma Concentration of Teduglutide at Nominal Time Points (Baseline at Pre-dose, and 1 Hour and 4 Hours Post-dose; 2 Hours Post-dose at Week 7)

Time frame · Baseline: Pre-dose,1, 4 hours post-dose, and 2 hours post-dose at Week 7

Mean plasma concentration of teduglutide was reported.

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame · From start of study treatment up to end of study (EOS) (up to Week 28)

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs that start or deteriorate on or after the date of the first dose of investigational product.

Change From Baseline in Body Weight Z-score at Week 24

Time frame · Baseline, Week 24

Body weight was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population)/standard deviation value of reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in body weight Z-score at Week 24 was reported.

Change From Baseline in Length Z-Score at Week 24

Time frame · Baseline, Week 24

Length was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population)/standard deviation value of reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in length Z-score at Week 24 was reported.

Change From Baseline in Head Circumference Z-Score at Week 24

Time frame · Baseline, Week 24

Head circumference was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population)/standard deviation value of reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in head circumference Z-score at Week 24 was reported.

Change From Baseline in Weight-for-Length Z-Score at Week 24

Time frame · Baseline, Week 24

Weight-for-length was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population)/standard deviation value of reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in weight-for-length Z-score at Week 24 was reported.

Change From Baseline in Average Total Urine Output at Week 24

Time frame · Baseline, Week 24

Average total urine output was recorded over a 48-hour period of nutritional stability at Week 24 was reported. Here, milliliter per kilogram per day is abbreviated as mL/kg/day.

Change From Baseline in Fecal Output at Week 24

Time frame · Baseline, Week 24

Change from baseline in the fecal output (average number of stools per day) at Week 24 was reported.

Number of Participants With Positive Specific Antibodies to Teduglutide

Time frame · Baseline, EOS (up to week 28)

Number of participants with positive specific antibodies to teduglutide were used to summarize the presence of antibodies.

Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Weight-normalized Parenteral Support (PS) Caloric Intake at End of Treatment/Early Termination (EOT/ET)

Time frame · Baseline, EOT/ET (up to Week 24)

Number of participants who achieved at least 20% reduction from baseline in weight-normalized PS caloric intake at EOT/ET (up to Week 24) were reported. EOT/ET was defined as the last available visit after the date of first dose (or randomization in standard of care treatment group) during the 24-week treatment period.