Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame · From start of study treatment up to 28 weeks
Registry description
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs that started or worsened on or after the date of first dose for treatment groups and those that started or worsened on or after the baseline visit for standard of care group.
Number of Participants Who Were Completely Weaned Off Parenteral Nutrition Intravenous (PN/IV) Support at Week 24
Time frame · Week 24
Registry description
A participant was considered to have achieved independence from PN/IV support (completely weaned off PN/IV) if the investigator prescribed no PN/IV at EOT and there was no use of PN/IV recorded in the participant diary during the week prior to EOT.
Change From Baseline in Parenteral Nutrition Intravenous (PN/IV) Volume at Week 24
Time frame · Baseline, Week 24
Registry description
Change in PN/IV volume was reported based on the participant diary and the investigator prescribed data.
Change From Baseline in Parenteral Nutrition Intravenous (PN/IV) Caloric Intake at Week 24
Time frame · Baseline, Week 24
Registry description
Change in PN/IV caloric intake was reported based on the participant diary and the investigator prescribed data.
Change From Baseline in Plasma Citrulline Levels at Week 24
Time frame · Baseline, Week 24
Registry description
Plasma citrulline level was reported.
Change From Baseline in Enteral Nutrition Volume at Week 24
Time frame · Baseline, Week 24
Registry description
Enteral nutrition was defined as specialized formula taken orally or by tube feeding, and excluded table foods and other fluids. Change in enteral nutrition volume was reported.
Change From Baseline in Enteral Nutrition Caloric Intake at Week 24
Time frame · Baseline, Week 24
Registry description
Enteral nutrition was defined as specialized formula taken orally or by tube feeding, and excluded table foods and other fluids. Change in enteral nutrition caloric intake was reported.
Change From Week 24 in Parenteral Nutrition Intravenous (PN/IV) Volume at Week 28
Time frame · Week 24, Week 28
Registry description
Change in PN/IV volume was reported.
Change From Week 24 in Parenteral Nutrition Intravenous (PN/IV) Caloric Intake at Week 28
Time frame · Week 24, Week 28
Registry description
Change in PN/IV caloric intake was reported.
Change From Week 24 in Plasma Citrulline Levels at Week 28
Time frame · Week 24, Week 28
Registry description
Change in plasma citrulline level was reported.
Change From Week 24 in Enteral Nutrition Volume at Week 28
Time frame · Week 24, Week 28
Registry description
Enteral nutrition was defined as specialized formula taken orally or by tube feeding, and excluded table foods and other fluids. Change in enteral nutrition volume was reported.
Change From Week 24 in Enteral Nutrition Caloric Intake at Week 28
Time frame · Week 24, Week 28
Registry description
Enteral nutrition was defined as specialized formula taken orally or by tube feeding, and excluded table foods and other fluids. Change in enteral nutrition caloric intake was reported.
Change From Baseline in Body Weight Z-score at Week 28
Time frame · Baseline, Week 28
Registry description
Body weight z-score is a measure of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.
Change From Baseline in Body Height Z-score at Week 28
Time frame · Baseline, Week 28
Registry description
Body height z-score is a measure of relative height adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.
Change From Baseline in Head Circumference Z-score at Week 28
Time frame · Baseline, Week 28
Registry description
Head circumference z-score is a measure of relative head circumference adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. Head circumference was collected only for participants of less than or equal to (\<=) 36 months of age at the time of measurement.
Change From Baseline in Body Mass Index (BMI) Z-score at Week 28
Time frame · Baseline, Week 28
Registry description
BMI z-score is a measure of relative BMI adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.
Change From Baseline in Participants' Stool Consistency at Week 28
Time frame · Baseline, Week 28
Registry description
Stool consistency was assessed by typical stool form based on Bristol Stool Form Scale: 1 - Separate hard lumps, hard to pass, 2 - Sausage-shaped, but lumpy, 3 - Like a sausage but with cracks on the surface, 4 - Like a sausage or snake, smooth and soft, 5 - Soft blobs with clear-cut edges, 6 - Fluffy pieces with ragged edges, a mushy stool, 7 - Watery, no solid pieces, entirely liquid.
Change From Baseline in Hours Per Day of Parenteral Nutrition Intravenous (PN/IV) Support at Week 24
Time frame · Baseline, Week 24
Registry description
The mean duration of the PN/IV infusions in hours, on the days when PN/IV was administered was reported.
Change From Baseline in Days Per Week of Parenteral Nutrition Intravenous (PN/IV) Support at Week 24
Time frame · Baseline, Week 24
Registry description
The number of days per week of PN/IV infusions were reported.