Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)

• Sponsor: Shire (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02954458
• Collaborator: (none)
• Enrollment: 61
• Locations: 22
• Arm: 1
• Actual Duration (Months): 45.9
• Patients Per Site: 2.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study will follow participants who completed the TED-C14-006 study. The purpose of this study is to evaluate the long-term safety and efficacy of teduglutide in pediatric participants with Short Bowel Syndrome (SBS). This study will also offer teduglutide treatment to eligible participants, regardless of treatment received in TED-C14-006 or SHP633-301.

Condition or Disease	Intervention/Treatment	Phase
Short Bowel Syndrome	Drug: TED; Other: SOC; Device: Syringe; Device: Needle	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Patients With Short Bowel Syndrome Who Completed TED-C14-006 or SHP633-301
• Actual Study Start Date: Jan 9, 2017
• Actual Primary Completion Date: Nov 5, 2020
• Actual Study Completion Date: Nov 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Standard of care (SOC) treatment +/- teduglutide (TED) Participants will receive 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily into 1 of the 4 quadrants of the abdomen or into either the thigh or arm as needed in addition to SOC treatment.	Drug: TED; 0.05 mg/kg SC injection once daily.; Other: SOC; Standard safety assessments and adjustments in nutritional support.; Device: Syringe; Teduglutide will be administered using syringe.; Device: Needle; Teduglutide will be administered using needle.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) [From start of study drug administration up to follow-up (up to 46 months)]

   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 were defined as AEs that started or worsened on or after the date of first dose of teduglutide for participants in the TED/TED, TED/NTT, and NTT/TED treatment groups, or after the core study baseline visit for participants in the NTT/NTT group.

2. Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment [Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

   Average total urine output was recorded over a 48-hour period of parental support (PS) stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily urine output milliliter per kilogram per day (mL/kg/day) was calculated as: Total urine output over 48 hours / 2) / body weight (kilogram [kg]) where total urine output was calculated as the sum of the urine output in milliliter (mL) and the urine-only diaper weights in gram (g) (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF).

3. Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide Treatment (NT) [Baseline, Last visit in NT (up to Month 39)]

   Average total urine output was recorded over a 48 hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. Average daily urine output mL/kg/day was calculated as: (Total urine output over 48 hours/2) / body weight (kg) where total urine output was calculated as the sum of the urine output in mL and the urine-only diaper weights in gram (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF).

4. Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment [Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

   Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2).

5. Change From Baseline in Average Number of Stools Per Day at Last Visit During Non-Teduglutide Treatment (NT) [Baseline, Last visit in NT (up to Month 39)]

   Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2).

6. Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment [Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

   Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average total daily stool/mixed stool diaper weight (gram per kilogram per day [g/kg/day]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day).

7. Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at Last Visit During Non-Teduglutide Treatment (NT) [Baseline, Last visit in NT (up to Month 39)]

   Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average total daily stool/mixed stool diaper weight (gram per kilogram per day [g/kg/day]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day).

8. Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment [Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

   Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average ostomy output per day (mL/kg/day).

9. Change From Baseline in Average Total Ostomy Output at Last Visit During Non-Teduglutide Treatment (NT) [Baseline, Last visit in NT (up to Month 39)]

   Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average ostomy output per day.

10. Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment [Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

    Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily fecal output was summarized the average typical stool form score using Bristol Stool Form Scale. The average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). 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.

11. Change From Baseline in Average Bristol Stool Form Score at Last Visit During Non-Teduglutide Treatment (NT) [Baseline, Last visit in NT (up to Month 39)]

    Fecal output was recorded over a 48 hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized separately the average typical stool form score using Bristol Stool Form Scale. The average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). 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.

12. Number of Participants With Positive Specific Antibodies at End of Study (EOS) [At EOS (up to 46 months)]

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

13. Change From Baseline in Body Weight Z-score at EOT of Last Cycle During Teduglutide Treatment [Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

    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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.

14. Change From Baseline in Body Weight Z-score at Last Visit During Non-Teduglutide Treatment (NT) [Baseline, Last visit in NT (up to Month 39)]

    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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.

15. Change From Baseline in Height Z-score at EOT of Last Cycle During Teduglutide Treatment [Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

    Height was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.

16. Change From Baseline in Height Z-score at Last Visit During Non-Teduglutide Treatment [Baseline, Last visit in NT (up to Month 39)]

    Height was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.

17. Change From Baseline in Head Circumference Z-score at EOT of Last Cycle During Teduglutide Treatment [Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

    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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.

18. Change From Baseline in Head Circumference Z-score at Last Visit During Non-Teduglutide Treatment (NT) [Baseline, Last visit in NT (up to Month 39)]

    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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.

19. Change From Baseline in Body Mass Index (BMI) Z-score at EOT of Last Cycle During Teduglutide Treatment [Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

    BMI Z-score was calculated by using the height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.

20. Change From Baseline in Body Mass Index (BMI) Z-score at Last Visit During Non-Teduglutide Treatment (NT) [Baseline, Last visit in NT (up to Month 39)]

    BMI Z-score was calculated by using the height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.

Secondary Outcome Measures

1. Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

   Number of participants who achieved at least 20%, 50%, and 75% reduction from baseline in diary PS volume at EOT of last cycle during teduglutide treatment was reported.

2. Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

   Number of participants who achieved at least 20%, 50%, and 75% reduction from baseline in prescribed PS volume at EOT of east cycle during teduglutide treatment was reported.

3. Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

   Change from baseline in diary PS volume at EOT of each cycle during teduglutide treatment was reported.

4. Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

   Percent change from baseline in diary PS volume at EOT of each cycle during teduglutide treatment was reported.

5. Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

   Change from baseline in prescribed PS volume at EOT of each cycle during teduglutide treatment was reported.

6. Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

   Percent Change from baseline in prescribed PS volume at EOT of each cycle during teduglutide treatment was reported.

7. Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

   Change from baseline in diary PS caloric intake at EOT of each cycle during teduglutide treatment was reported. Here, kilo-calories per kilogram per day was abbreviated as (kcal/kg/day).

8. Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

   Percent change from baseline in diary PS Caloric intake at EOT of each cycle during teduglutide treatment was reported.

9. Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

   Change from baseline in prescribed PS caloric intake at EOT of each cycle during teduglutide treatment was reported.

10. Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

    Percent change from baseline in prescribed PS caloric intake at EOT of each cycle during teduglutide treatment was reported.

11. Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

    Number of participants who achieved at least 100% reduction in complete weaning of PS volume at EOT of each cycle during teduglutide treatment was reported.

12. Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

    Change from baseline in hours per day of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of diary PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).

13. Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

    Percent change from baseline in hours per day of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of diary PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).

14. Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

    Change from baseline in hours per day of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of dairy PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).

15. Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

    Percent change from baseline in hours per day of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of dairy PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).

16. Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

    Change from baseline in days per week of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7.

17. Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

    Percent change from baseline in days per week of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7.

18. Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

    Change from baseline in days per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of dairy PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7

19. Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

    Percent change from baseline in days per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of dairy PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7.

Other Outcome Measures

1. Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

   PedsQL GCS was designed to measure health-related quality of life in pediatric participants and adolescents (2 to 18 years of age). It encompasses 4 dimensions of functioning (physical [8 items], emotional [5 items], social [5 items], school [3 items]). Age groups were: Toddler (2-4 years), Young pediatric (5-7 years), Pediatric (8-12 years), and Teens (13-18 years). Depending on the participant's age, the questionnaire may be completed by parent/caregiver as appropriate. For the Toddler group, the PedsQL GCS consisted of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consisted of 23 items, with a 3-point Likert scale (0, 2, 4) for the young pediatric, and a 5-point Likert scale for the pediatric and teens groups. Scores are transformed on a scale from 0 to 100 where 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.

2. Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT) [Baseline, Last visit in NT (up to Month 39)]

   PedsQL GCS was designed to measure health-related quality of life in pediatric participants and adolescents (2 to 18 years of age). It encompasses 4 dimensions of functioning (physical [8 items], emotional [5 items], social [5 items], school [3 items]). Age groups were: Toddler (2-4 years), Young pediatric (5-7 years), Pediatric (8-12 years), and Teens (13-18 years). Depending on the participant's age, the questionnaire may be completed by parent/caregiver as appropriate. For the Toddler group, the PedsQL GCS consisted of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consisted of 23 items, with a 3-point Likert scale (0, 2, 4) for the young pediatric, and a 5-point Likert scale for the pediatric and teens groups. Scores are transformed on a scale from 0 to 100 where 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.

3. Change From Baseline In PedsQL Total Family Impact Module Score at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

   PedsQL Family Impact Module was composed of 36 items comprising Physical Functioning (6 items), Emotional Functioning (5 items), Social Functioning (4 items), Cognitive Functioning (5 items), Communication (3 items), Worry (5 items), Daily Activities (3 items) and Family Relationships (5 items). Total family impact score was calculated as the sum of all the items over the number of items answered on all the scales. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.

4. Change From Baseline In PedsQL Total Family Impact Module Score at Last Visit During Non-Teduglutide Treatment (NT) [Baseline, Last visit in NT (up to Month 39)]

   PedsQL Family Impact Module was composed of 36 items comprising Physical Functioning (6 items), Emotional Functioning (5 items), Social Functioning (4 items), Cognitive Functioning (5 items), Communication (3 items), Worry (5 items), Daily Activities (3 items) and Family Relationships (5 items). Total family impact score was calculated as the sum of all the items over the number of items answered on all the scales. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life

5. Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment [Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)]

   PedsQL Gastrointestinal symptoms module was composed of 58 items, comprised of 10 different symptom scales that assess gastrointestinal symptom-related quality of life: food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea. Only the scales of food and drink limits (6 items) and diarrhea (7 items) was used in this study. Sub-scale score was calculated as the sum of the items over the number of items answered in the scale. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.

6. Change From Baseline In PedsQL Gastrointestinal Symptoms Module at Last Visit During Non-Teduglutide Treatment (NT) [Baseline, Last visit in NT (up to Month 39)]

   PedsQL gastrointestinal symptoms module was composed of 58 items, comprised of 10 different symptom scales that assess gastrointestinal symptom-related quality of life: food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea. Only the scales of food and drink limits (6 items) and diarrhea (7 items) was used in this study. Sub-scale score was calculated as the sum of the items over the number of items answered in the scale. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Participant provides written informed consent (participant, parent or legal guardian and, as appropriate, informed assent) to participate in the study before completing any study-related procedures.

2. Participant completed the TED-C14-006 or SHP633-301 studies (including participants in the standard of care treatment arms). Participants are considered to have completed SHP633-301 if they completed study assessments through week 24.

3. Participant understands and is willing and able to fully adhere to study requirements as defined in this protocol.

Exclusion Criteria:

1. There are no exclusion criteria for this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Childrens Hospital Los Angeles - RHU	Los Angeles	California	United States	90027-6062
2	Mattel Children's Hospital UCLA	Los Angeles	California	United States	90095
3	UCSF Benioff Children's Hospital	San Francisco	California	United States	94158-2531
4	Georgetown Children's Research Network	Washington	District of Columbia	United States	20007
5	Riley Hospital for Children	Indianapolis	Indiana	United States	46202
6	Boston Children's Hospital	Boston	Massachusetts	United States	02115
7	The Nebraska Medical Center	Omaha	Nebraska	United States	68198
8	Children's Hosp. at Montefiore	Bronx	New York	United States	10467-2403
9	Columbia Unversity Medical Center	New York	New York	United States	07024
10	Duke Medical Center	Durham	North Carolina	United States	27710
11	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
12	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
13	Texas Children's Hospital	Houston	Texas	United States	77030
14	Seattle Children's Hospital	Seattle	Washington	United States	98105
15	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin	United States	53792
16	Cliniques Universitaires Saint-Luc	Bruxelles	Woluwe-Saint-Lambert	Belgium	1200
17	Walter C. Mackenzie Health Science Centre	Edmonton	Alberta	Canada	T6G 1C9
18	The Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8
19	Helsingin yliopistollinen keskussairaala	Helsinki		Finland	00290
20	Ospedale Pediatrico Bambino Gesu	Roma		Italy	00165
21	Great Ormond Children's Hosp	London	Greater London	United Kingdom	WC1N 3JH
22	Birmingham Children's Hospital	Birmingham	West Midlands	United Kingdom	B4 6NH

Sponsors and Collaborators

• Shire

Investigators

• Study Director: Study Director, Shire

Study Documents (Full-Text)

• Study Protocol - Oct 1, 2019
• Statistical Analysis Plan - Dec 17, 2020

More Information

Additional Information:

• To obtain more information on the study, click here/on this link

Publications

None provided.

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT02954458
• Other Study ID Numbers: SHP633-304; 2016-000849-30
• First Posted: Nov 3, 2016
• Last Update Posted: Oct 13, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Short Bowel Syndrome; Syndrome

Study Results

Participant Flow

Recruitment Details

The study was conducted at 23 sites between 09 January 2017 and 05 November 2020. A total of 61 participants (children and infant) were enrolled and classified into treatment groups (NTT/NTT, NTT/TED , TED/NTT, and TED/TED) based on whether they received teduglutide in their core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] and/or during this extension study. Participants who completed their core study were eligible for this extension study.

Pre-assignment Detail

NTT/NTT: Participants who participated in standard of care (SOC) arm in the core study and didn't receive any TED treatment in this extension study; NTT/TED: Participants who participated in SOC arm in the core study but who subsequently received TED in this extension study; TED/NTT: Participants who received TED in the core study but didn't receive any TED treatment in this extension study; TED/TED: Participants who received TED in the core study and in this extension study.

Arm/Group Title	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide /Non-teduglutide Treatment (TED/NTT)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Period Title: Overall Study
STARTED	7	3	1	50
COMPLETED	6	3	0	38
NOT COMPLETED	1	0	1	12

Baseline Characteristics

Arm/Group Title	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide /Non-teduglutide Treatment (TED/NTT)	Teduglutide/Teduglutide Treatment (TED/TED)	Total
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.	Total of all reporting groups
Overall Participants	7	3	1	50	61
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	5.8 (5.43)	1.5 (0.80)	6.0 (NA)	5.7 (3.69)	5.5 (3.86)
Sex: Female, Male (Count of Participants)
Female	3 42.9%	1 33.3%	0 0%	16 32%	20 32.8%
Male	4 57.1%	2 66.7%	1 100%	34 68%	41 67.2%
Race/Ethnicity, Customized (Count of Participants)
White	3 42.9%	0 0%	1 100%	38 76%	42 68.9%
Black or African American	1 14.3%	0 0%	0 0%	6 12%	7 11.5%
Asian	1 14.3%	1 33.3%	0 0%	1 2%	3 4.9%
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Other	1 14.3%	1 33.3%	0 0%	1 2%	3 4.9%
Not allowed based on local regulations	1 14.3%	1 33.3%	0 0%	4 8%	6 9.8%
Race/Ethnicity, Customized (Count of Participants)
Hispanic or Latino	3 42.9%	1 33.3%	0 0%	10 20%	14 23%
Not Hispanic or Latino	3 42.9%	1 33.3%	1 100%	35 70%	40 65.6%
Not allowed based on local regulations	1 14.3%	1 33.3%	0 0%	5 10%	7 11.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description	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 were defined as AEs that started or worsened on or after the date of first dose of teduglutide for participants in the TED/TED, TED/NTT, and NTT/TED treatment groups, or after the core study baseline visit for participants in the NTT/NTT group.
Time Frame	From start of study drug administration up to follow-up (up to 46 months)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria.

Arm/Group Title	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide /Non-teduglutide Treatment (TED/NTT)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	7	3	1	50
Count of Participants [Participants]	6 85.7%	3 100%	1 100%	50 100%

2. Primary Outcome

Title	Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment
Description	Average total urine output was recorded over a 48-hour period of parental support (PS) stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily urine output milliliter per kilogram per day (mL/kg/day) was calculated as: Total urine output over 48 hours / 2) / body weight (kilogram [kg]) where total urine output was calculated as the sum of the urine output in milliliter (mL) and the urine-only diaper weights in gram (g) (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF).
Time Frame	Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	2	32
Mean (Standard Deviation) [mL/kg/day]	0.26 (1.692)	2.51 (22.607)

3. Primary Outcome

Title	Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide Treatment (NT)
Description	Average total urine output was recorded over a 48 hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. Average daily urine output mL/kg/day was calculated as: (Total urine output over 48 hours/2) / body weight (kg) where total urine output was calculated as the sum of the urine output in mL and the urine-only diaper weights in gram (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF).
Time Frame	Baseline, Last visit in NT (up to Month 39)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm/Group Title	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide /Non-teduglutide Treatment (TED/NTT)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	4	0	1	11
Mean (Standard Deviation) [mL/kg/day]	-0.89 (7.431)	15.01 (NA)	-6.87 (26.299)

4. Primary Outcome

Title	Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment
Description	Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2).
Time Frame	Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	0	32
Mean (Standard Deviation) [Stools per day]	-0.47 (2.272)

5. Primary Outcome

Title	Change From Baseline in Average Number of Stools Per Day at Last Visit During Non-Teduglutide Treatment (NT)
Description	Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2).
Time Frame	Baseline, Last visit in NT (up to Month 39)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm/Group Title	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide /Non-teduglutide Treatment (TED/NTT)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	4	0	0	14
Mean (Standard Deviation) [Stools per day]	-0.50 (0.913)	0.38 (1.780)

6. Primary Outcome

Title	Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment
Description	Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average total daily stool/mixed stool diaper weight (gram per kilogram per day [g/kg/day]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day).
Time Frame	Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	1	7
Mean (Standard Deviation) [g/kg/day]	0.00 (NA)	-11.35 (25.667)

7. Primary Outcome

Title	Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at Last Visit During Non-Teduglutide Treatment (NT)
Description	Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average total daily stool/mixed stool diaper weight (gram per kilogram per day [g/kg/day]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day).
Time Frame	Baseline, Last visit in NT (up to Month 39)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm/Group Title	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide /Non-teduglutide Treatment (TED/NTT)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	1	0	0	4
Mean (Standard Deviation) [g/kg/day]	0.31 (NA)	-4.98 (20.892)

8. Primary Outcome

Title	Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment
Description	Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average ostomy output per day (mL/kg/day).
Time Frame	Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	2	5
Mean (Standard Deviation) [mL/kg/day]	-12.52 (11.675)	12.16 (35.079)

9. Primary Outcome

Title	Change From Baseline in Average Total Ostomy Output at Last Visit During Non-Teduglutide Treatment (NT)
Description	Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average ostomy output per day.
Time Frame	Baseline, Last visit in NT (up to Month 39)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm/Group Title	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide /Non-teduglutide Treatment (TED/NTT)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	0	0	0	2
Mean (Standard Deviation) [mL/kg/day]	23.89 (37.835)

10. Primary Outcome

Title	Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment
Description	Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily fecal output was summarized the average typical stool form score using Bristol Stool Form Scale. The average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). 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.
Time Frame	Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	0	32
Mean (Standard Deviation) [Scale on a Score]	-0.54 (0.977)

11. Primary Outcome

Title	Change From Baseline in Average Bristol Stool Form Score at Last Visit During Non-Teduglutide Treatment (NT)
Description	Fecal output was recorded over a 48 hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized separately the average typical stool form score using Bristol Stool Form Scale. The average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). 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.
Time Frame	Baseline, Last visit in NT (up to Month 39)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm/Group Title	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide /Non-teduglutide Treatment (TED/NTT)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	4	0	1	14
Mean (Standard Deviation) [Scale on a Score]	-0.25 (0.500)	0.00 (NA)	-0.08 (0.583)

12. Primary Outcome

Title	Number of Participants With Positive Specific Antibodies at End of Study (EOS)
Description	Number of participants with positive specific antibodies to teduglutide were used to summarize the presence of antibodies.
Time Frame	At EOS (up to 46 months)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for the 3 arms: NTT/TED, TED/NTT and TED/TED only.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide /Non-teduglutide Treatment (TED/NTT)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	1	40
Count of Participants [Participants]	2 28.6%	0 0%	10 1000%

13. Primary Outcome

Title	Change From Baseline in Body Weight Z-score at EOT of Last Cycle During Teduglutide Treatment
Description	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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
Time Frame	Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	2	43
Mean (Standard Deviation) [Z-score]	0.087 (0.422)	-0.164 (0.951)

14. Primary Outcome

Title	Change From Baseline in Body Weight Z-score at Last Visit During Non-Teduglutide Treatment (NT)
Description	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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
Time Frame	Baseline, Last visit in NT (up to Month 39)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm/Group Title	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide /Non-teduglutide Treatment (TED/NTT)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	1	1	19
Mean (Standard Deviation) [Z-score]	-0.489 (0.542)	-0.132 (NA)	0.013 (NA)	-0.363 (0.657)

15. Primary Outcome

Title	Change From Baseline in Height Z-score at EOT of Last Cycle During Teduglutide Treatment
Description	Height was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
Time Frame	Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	2	27
Mean (Standard Deviation) [Z-score]	0.118 (0.968)	-0.277 (0.797)

16. Primary Outcome

Title	Change From Baseline in Height Z-score at Last Visit During Non-Teduglutide Treatment
Description	Height was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
Time Frame	Baseline, Last visit in NT (up to Month 39)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm/Group Title	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide /Non-teduglutide Treatment (TED/NTT)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	1	1	18
Mean (Standard Deviation) [Z-score]	-0.518 (0.451)	-0.770 (NA)	0.220 (NA)	-0.132 (0.466)

17. Primary Outcome

Title	Change From Baseline in Head Circumference Z-score at EOT of Last Cycle During Teduglutide Treatment
Description	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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
Time Frame	Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	0	2
Mean (Standard Deviation) [Z-score]	-0.727 (0.440)

18. Primary Outcome

Title	Change From Baseline in Head Circumference Z-score at Last Visit During Non-Teduglutide Treatment (NT)
Description	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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
Time Frame	Baseline, Last visit in NT (up to Month 39)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm/Group Title	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide /Non-teduglutide Treatment (TED/NTT)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	0	0	0	1
Mean (Standard Deviation) [Z-score]	-0.309 (NA)

19. Primary Outcome

Title	Change From Baseline in Body Mass Index (BMI) Z-score at EOT of Last Cycle During Teduglutide Treatment
Description	BMI Z-score was calculated by using the height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
Time Frame	Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	2	43
Mean (Standard Deviation) [Z-score]	0.215 (0.142)	0.035 (0.904)

20. Primary Outcome

Title	Change From Baseline in Body Mass Index (BMI) Z-score at Last Visit During Non-Teduglutide Treatment (NT)
Description	BMI Z-score was calculated by using the height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
Time Frame	Baseline, Last visit in NT (up to Month 39)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm/Group Title	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide /Non-teduglutide Treatment (TED/NTT)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	1	1	19
Mean (Standard Deviation) [Z-score]	-0.545 (1.335)	0.791 (NA)	-0.564 (NA)	-0.148 (0.555)

21. Secondary Outcome

Title	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment
Description	Number of participants who achieved at least 20%, 50%, and 75% reduction from baseline in diary PS volume at EOT of last cycle during teduglutide treatment was reported.
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment. Number of participants in each categories are mutually exhaustive at each time point.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	50
Change at EOT of Cycle 1: >= 20% Reduction	1 14.3%	29 966.7%
Change at EOT of Cycle 1: >= 50% Reduction	0 0%	13 433.3%
Change at EOT of Cycle 1: >= 75% Reduction	0 0%	7 233.3%
Change at EOT of Cycle 2: >= 20% Reduction	1 14.3%	29 966.7%
Change at EOT of Cycle 2: >= 50% Reduction	0 0%	17 566.7%
Change at EOT of Cycle 2: >= 75% Reduction	0 0%	9 300%
Change at EOT of Cycle 3: >= 20% Reduction	2 28.6%	22 733.3%
Change at EOT of Cycle 3: >= 50% Reduction	0 0%	14 466.7%
Change at EOT of Cycle 3: >= 75% Reduction	0 0%	6 200%
Change at EOT of Cycle 4: >= 20% Reduction	1 14.3%	20 666.7%
Change at EOT of Cycle 4: >= 50% Reduction	1 14.3%	13 433.3%
Change at EOT of Cycle 4: >= 75% Reduction	0 0%	7 233.3%
Change at EOT of Cycle 5: >= 20% Reduction	1 14.3%	15 500%
Change at EOT of Cycle 5: >= 50% Reduction	1 14.3%	13 433.3%
Change at EOT of Cycle 5: >= 75% Reduction	0 0%	6 200%
Change at EOT of Cycle 6: >= 20% Reduction	0 0%	2 66.7%
Change at EOT of Cycle 6: >= 50% Reduction	0 0%	2 66.7%
Change at EOT of Cycle 6: >= 75% Reduction	0 0%	1 33.3%
Change at EOT of Last Cycle: >= 20% Reduction	3 42.9%	29 966.7%
Change at EOT of Last Cycle: >= 50% Reduction	1 14.3%	21 700%
Change at EOT of Last Cycle: >= 75% Reduction	0 0%	11 366.7%

22. Secondary Outcome

Title	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment
Description	Number of participants who achieved at least 20%, 50%, and 75% reduction from baseline in prescribed PS volume at EOT of east cycle during teduglutide treatment was reported.
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	50
EOT of Cycle 1: >= 20% Reduction in PS Volume	2 28.6%	35 1166.7%
EOT of Cycle 1: >= 50% Reduction in PS Volume	0 0%	18 600%
EOT of Cycle 1: >= 75% Reduction in PS Volume	0 0%	9 300%
EOT of Cycle 2: >= 20% Reduction in PS Volume	2 28.6%	31 1033.3%
EOT of Cycle 2: >= 50% Reduction in PS Volume	2 28.6%	18 600%
EOT of Cycle 2: >= 75% Reduction in PS Volume	1 14.3%	11 366.7%
EOT of Cycle 3: >= 20% Reduction in PS Volume	2 28.6%	24 800%
EOT of Cycle 3: >= 50% Reduction in PS Volume	1 14.3%	14 466.7%
EOT of Cycle 3: >= 75% Reduction in PS Volume	1 14.3%	7 233.3%
EOT of Cycle 4: >= 20% Reduction in PS Volume	1 14.3%	21 700%
EOT of Cycle 4: >= 50% Reduction in PS Volume	1 14.3%	13 433.3%
EOT of Cycle 4: >= 75% Reduction in PS Volume	0 0%	7 233.3%
EOT of Cycle 5: >= 20% Reduction in PS Volume	1 14.3%	17 566.7%
EOT of Cycle 5: >= 50% Reduction in PS Volume	1 14.3%	12 400%
EOT of Cycle 5: >= 75% Reduction in PS Volume	0 0%	6 200%
EOT of Cycle 6: >= 20% Reduction in PS Volume	2 28.6%
EOT of Cycle 6: >= 50% Reduction in PS Volume	2 28.6%
EOT of Cycle 6: >= 75% Reduction in PS Volume	0 0%
EOT of Last Cycle: >= 20% Reduction in PS Volume	3 42.9%	37 1233.3%
EOT of Last Cycle: >= 50% Reduction in PS Volume	2 28.6%	23 766.7%
EOT of Last Cycle: >= 75% Reduction in PS Volume	1 14.3%	12 400%

23. Secondary Outcome

Title	Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment
Description	Change from baseline in diary PS volume at EOT of each cycle during teduglutide treatment was reported.
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	39
Change at EOT of Cycle 1	-14.87 (4.574)	-22.63 (18.125)
Change at EOT of Cycle 2	-8.98 (10.490)	-25.75 (22.480)
Change at EOT of Cycle 3	-34.81 (15.314)	-32.01 (28.837)
Change at EOT of Cycle 4	-57.45 (NA)	-32.61 (24.639)
Change at EOT of Cycle 5	-56.90 (NA)	-38.76 (21.148)
Change at EOT of Cycle 6	-40.51 (24.833)
Change at EOT of Last Cycle	-33.39 (20.503)	-29.36 (25.514)

24. Secondary Outcome

Title	Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment
Description	Percent change from baseline in diary PS volume at EOT of each cycle during teduglutide treatment was reported.
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	39
Percent Change at EOT of Cycle 1	-23.23 (15.103)	-41.88 (34.100)
Percent Change at EOT of Cycle 2	-13.29 (16.826)	-45.67 (38.377)
Percent Change at EOT of Cycle 3	-38.66 (2.603)	-46.62 (37.756)
Percent Change at EOT of Cycle 4	-50.99 (NA)	-51.28 (36.364)
Percent Change at EOT of Cycle 5	-50.50 (NA)	-58.86 (33.522)
Percent Change at EOT of Cycle 6	-52.87 (32.722)
Percent Change at EOT of Last Cycle	-42.65 (7.061)	-50.27 (38.917)

25. Secondary Outcome

Title	Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment
Description	Change from baseline in prescribed PS volume at EOT of each cycle during teduglutide treatment was reported.
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	50
Change at EOT of Cycle 1	-22.57 (13.957)	-20.87 (20.957)
Change at EOT of Cycle 2	-65.88 (12.621)	-24.24 (24.914)
Change at EOT of Cycle 3	-58.82 (4.022)	-30.53 (26.449)
Change at EOT of Cycle 4	-68.72 (NA)	-34.53 (23.849)
Change at EOT of Cycle 5	-68.99 (NA)	-37.78 (22.850)
Change at EOT of Cycle 6	-39.10 (24.154)
Change at EOT of Last Cycle	-48.23 (25.528)	-26.26 (25.275)

26. Secondary Outcome

Title	Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment
Description	Percent Change from baseline in prescribed PS volume at EOT of each cycle during teduglutide treatment was reported.
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	50
Percent Change at EOT of Cycle 1	-28.82 (12.660)	-34.43 (52.810)
Percent Change at EOT of Cycle 2	-73.03 (18.304)	-42.38 (42.375)
Percent Change at EOT of Cycle 3	-67.01 (24.723)	-44.07 (36.002)
Percent Change at EOT of Cycle 4	-55.20 (NA)	-52.78 (33.033)
Percent Change at EOT of Cycle 5	-55.42 (NA)	-57.42 (34.250)
Percent Change at EOT of Cycle 6	-52.62 (33.377)
Percent Change at EOT of Last Cycle	-60.20 (22.297)	-40.89 (55.305)

27. Secondary Outcome

Title	Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment
Description	Change from baseline in diary PS caloric intake at EOT of each cycle during teduglutide treatment was reported. Here, kilo-calories per kilogram per day was abbreviated as (kcal/kg/day).
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	39
Change at EOT of Cycle 1	-16.95 (15.141)	-17.40 (13.401)
Change at EOT of Cycle 2	-10.46 (0.023)	-18.71 (16.722)
Change at EOT of Cycle 3	-20.77 (0.206)	-22.09 (18.009)
Change at EOT of Cycle 4	-34.01 (NA)	-24.67 (18.859)
Change at EOT of Cycle 5	-33.68 (NA)	-30.20 (13.754)
Change at EOT of Cycle 6	-34.46 (20.080)
Change at EOT of Last Cycle	-24.98 (7.540)	-21.13 (18.284)

28. Secondary Outcome

Title	Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment
Description	Percent change from baseline in diary PS Caloric intake at EOT of each cycle during teduglutide treatment was reported.
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	39
Percent Change at EOT of Cycle 1	-35.21 (31.088)	-45.91 (35.484)
Percent Change at EOT of Cycle 2	-14.63 (1.162)	-48.66 (38.282)
Percent Change at EOT of Cycle 3	-29.03 (2.083)	-46.75 (38.042)
Percent Change at EOT of Cycle 4	-50.31 (NA)	-53.23 (37.611)
Percent Change at EOT of Cycle 5	-49.81 (NA)	-64.30 (30.289)
Percent Change at EOT of Cycle 6	-50.89 (25.667)
Percent Change at EOT of Last Cycle	-45.98 (16.836)	-52.02 (41.386)

29. Secondary Outcome

Title	Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment
Description	Change from baseline in prescribed PS caloric intake at EOT of each cycle during teduglutide treatment was reported.
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	49
Change at EOT of Cycle 1	-16.94 (15.187)	-15.80 (17.337)
Change at EOT of Cycle 2	-37.91 (38.003)	-16.00 (18.918)
Change at EOT of Cycle 3	-44.01 (27.532)	-20.18 (15.633)
Change at EOT of Cycle 4	-34.59 (NA)	-24.48 (15.899)
Change at EOT of Cycle 5	-34.76 (NA)	-27.83 (15.311)
Change at EOT of Cycle 6	-33.30 (19.205)
Change at EOT of Last Cycle	-39.68 (21.758)	-18.60 (19.507)

30. Secondary Outcome

Title	Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment
Description	Percent change from baseline in prescribed PS caloric intake at EOT of each cycle during teduglutide treatment was reported.
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	49
Percent Change at EOT of Cycle 1	-34.79 (31.100)	-40.67 (39.607)
Percent Change at EOT of Cycle 2	-50.00 (47.944)	-42.75 (45.563)
Percent Change at EOT of Cycle 3	-59.00 (32.825)	-44.74 (35.274)
Percent Change at EOT of Cycle 4	-50.45 (NA)	-54.32 (32.153)
Percent Change at EOT of Cycle 5	-50.69 (NA)	-59.49 (30.789)
Percent Change at EOT of Cycle 6	-50.67 (26.310)
Percent Change at EOT of Last Cycle	-64.50 (16.117)	-45.84 (42.242)

31. Secondary Outcome

Title	Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment
Description	Number of participants who achieved at least 100% reduction in complete weaning of PS volume at EOT of each cycle during teduglutide treatment was reported.
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	50
EOT of Cycle 1	0 0%	7 233.3%
EOT of Cycle 2	0 0%	8 266.7%
EOT of Cycle 3	0 0%	6 200%
EOT of Cycle 4	0 0%	6 200%
EOT of Cycle 5	0 0%	6 200%
EOT of Cycle 6	0 0%	0 0%
EOT of Last Cycle	0 0%	10 333.3%

32. Secondary Outcome

Title	Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment
Description	Change from baseline in hours per day of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of diary PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	39
Change at EOT of Cycle 1	-0.57 (0.990)	-3.58 (3.750)
Change at EOT of Cycle 2	-1.71 (2.424)	-3.55 (4.497)
Change at EOT of Cycle 3	-3.57 (2.222)	-4.19 (5.036)
Change at EOT of Cycle 4	-4.00 (NA)	-4.83 (5.069)
Change at EOT of Cycle 5	-4.00 (NA)	-5.64 (5.392)
Change at EOT of Cycle 6	-5.14 (4.536)
Change at EOT of Last Cycle	-3.05 (2.700)	-3.89 (4.881)

33. Secondary Outcome

Title	Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment
Description	Percent change from baseline in hours per day of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of diary PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	39
Percent Change at EOT of Cycle 1	-4.76 (8.248)	-33.43 (35.645)
Percent Change at EOT of Cycle 2	-14.29 (20.203)	-34.12 (41.982)
Percent Change at EOT of Cycle 3	-26.98 (22.448)	-35.11 (41.822)
Percent Change at EOT of Cycle 4	-22.22 (NA)	-40.68 (42.255)
Percent Change at EOT of Cycle 5	-22.22 (NA)	-47.07 (44.248)
Percent Change at EOT of Cycle 6	-42.86 (37.796)
Percent Change at EOT of Last Cycle	-21.69 (21.433)	-37.04 (45.049)

34. Secondary Outcome

Title	Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment
Description	Change from baseline in hours per day of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of dairy PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	50
Change at EOT of Cycle 1	0.00 (0.000)	-2.60 (4.279)
Change at EOT of Cycle 2	-3.00 (4.243)	-2.78 (5.479)
Change at EOT of Cycle 3	-1.00 (1.414)	-2.79 (5.400)
Change at EOT of Cycle 4	-4.00 (NA)	-3.43 (5.849)
Change at EOT of Cycle 5	-4.00 (NA)	-3.93 (6.070)
Change at EOT of Cycle 6	0.00 (0.000)
Change at EOT of Last Cycle	-1.33 (2.309)	-2.58 (5.666)

35. Secondary Outcome

Title	Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment
Description	Percent change from baseline in hours per day of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of dairy PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	49
Percent Change at EOT of Cycle 1	0.00 (0.000)	-21.27 (34.449)
Percent Change at EOT of Cycle 2	-16.67 (23.570)	-22.75 (47.101)
Percent Change at EOT of Cycle 3	-5.56 (7.857)	-20.64 (40.735)
Percent Change at EOT of Cycle 4	-22.22 (NA)	-25.47 (43.906)
Percent Change at EOT of Cycle 5	-22.22 (NA)	-32.28 (48.126)
Percent Change at EOT of Cycle 6	0.00 (0.000)
Percent Change at EOT of Last Cycle	-7.41 (12.830)	-20.91 (47.918)

36. Secondary Outcome

Title	Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment
Description	Change from baseline in days per week of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7.
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	39
Change at EOT of Cycle 1	-0.33 (0.577)	-1.41 (2.432)
Change at EOT of Cycle 2	-1.00 (1.414)	-1.76 (2.508)
Change at EOT of Cycle 3	-1.50 (2.121)	-2.13 (2.756)
Change at EOT of Cycle 4	0.00 (NA)	-2.36 (2.956)
Change at EOT of Cycle 5	0.00 (NA)	-2.70 (3.107)
Change at EOT of Cycle 6	-3.00 (2.646)
Change at EOT of Last Cycle	-1.00 (1.732)	-2.14 (2.720)

37. Secondary Outcome

Title	Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment
Description	Percent change from baseline in days per week of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7.
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	39
Percent Change at EOT of Cycle 1	-4.76 (8.248)	-23.40 (39.994)
Percent Change at EOT of Cycle 2	-14.29 (20.203)	-29.07 (41.805)
Percent Change at EOT of Cycle 3	-21.43 (30.305)	-31.37 (41.530)
Percent Change at EOT of Cycle 4	0.00 (NA)	-34.66 (44.475)
Percent Change at EOT of Cycle 5	0.00 (NA)	-39.50 (47.024)
Percent Change at EOT of Cycle 6	-42.86 (37.796)
Percent Change at EOT of Last Cycle	-14.29 (24.744)	-34.46 (43.755)

38. Secondary Outcome

Title	Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment
Description	Change from baseline in days per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of dairy PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	50
Change at EOT of Cycle 1	-0.33 (0.577)	-1.42 (2.251)
Change at EOT of Cycle 2	-1.00 (1.414)	-1.65 (2.399)
Change at EOT of Cycle 3	-1.50 (2.121)	-1.85 (2.623)
Change at EOT of Cycle 4	0.00 (NA)	-2.15 (2.852)
Change at EOT of Cycle 5	0.00 (NA)	-2.75 (3.041)
Change at EOT of Cycle 6	-3.00 (2.646)
Change at EOT of Last Cycle	-1.00 (1.732)	-1.92 (2.538)

39. Secondary Outcome

Title	Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment
Description	Percent change from baseline in days per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of dairy PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7.
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	50
Percent Change at EOT of Cycle 1	-4.76 (8.248)	-23.18 (36.926)
Percent Change at EOT of Cycle 2	-14.29 (20.203)	-27.41 (40.209)
Percent Change at EOT of Cycle 3	-21.43 (30.305)	-27.58 (40.258)
Percent Change at EOT of Cycle 4	0.00 (NA)	-32.12 (43.730)
Percent Change at EOT of Cycle 5	0.00 (NA)	-40.86 (46.839)
Percent Change at EOT of Cycle 6	-42.86 (37.796)
Percent Change at EOT of Last Cycle	-14.29 (24.744)	-30.71 (40.861)

40. Other Pre-specified Outcome

Title	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment
Description	PedsQL GCS was designed to measure health-related quality of life in pediatric participants and adolescents (2 to 18 years of age). It encompasses 4 dimensions of functioning (physical [8 items], emotional [5 items], social [5 items], school [3 items]). Age groups were: Toddler (2-4 years), Young pediatric (5-7 years), Pediatric (8-12 years), and Teens (13-18 years). Depending on the participant's age, the questionnaire may be completed by parent/caregiver as appropriate. For the Toddler group, the PedsQL GCS consisted of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consisted of 23 items, with a 3-point Likert scale (0, 2, 4) for the young pediatric, and a 5-point Likert scale for the pediatric and teens groups. Scores are transformed on a scale from 0 to 100 where 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	2	42
Physical Functioning: Change at EOT of Cycle 1	-21.88 (8.839)	-2.44 (22.323)
Physical Functioning: Change at EOT of Cycle 2	-18.75 (NA)	4.69 (22.327)
Physical Functioning: Change at EOT of Cycle 3	-18.75 (NA)	-5.80 (27.093)
Physical Functioning: Change at EOT of Cycle 4	-9.38 (NA)	4.12 (20.872)
Physical Functioning: Change at EOT of Cycle 5	-15.63 (NA)	4.83 (20.840)
Emotional Functioning: Change at EOT of Cycle 1	-7.50 (10.607)	-2.07 (16.807)
Emotional Functioning: Change at EOT of Cycle 2	5.00 (NA)	0.88 (15.249)
Emotional Functioning: Change at EOT of Cycle 3	-15.00 (NA)	-0.36 (20.680)
Emotional Functioning: Change at EOT of Cycle 4	5.00 (NA)	1.82 (22.811)
Emotional Functioning: Change at EOT of Cycle 5	0.00 (NA)	1.36 (23.674)
Social Functioning: Change at EOT of Cycle 1	-12.50 (17.678)	0.49 (18.262)
Social Functioning: Change at EOT of Cycle 2	-25.00 (NA)	5.29 (20.484)
Social Functioning: Change at EOT of Cycle 3	-30.00 (NA)	2.14 (24.662)
Social Functioning: Change at EOT of Cycle 4	-15.00 (NA)	3.86 (23.193)
Social Functioning: Change at EOT of Cycle 5	-15.00 (NA)	2.95 (20.458)
School Functioning: Change at EOT of Cycle 1	3.33 (25.111)
School Functioning: Change at EOT of Cycle 2	6.93 (27.096)
School Functioning: Change at EOT of Cycle 3	1.17 (33.804)
School Functioning: Change at EOT of Cycle 4	9.89 (25.233)
School Functioning: Change at EOT of Cycle 5	8.33 (23.721)

41. Other Pre-specified Outcome

Title	Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)
Description	PedsQL GCS was designed to measure health-related quality of life in pediatric participants and adolescents (2 to 18 years of age). It encompasses 4 dimensions of functioning (physical [8 items], emotional [5 items], social [5 items], school [3 items]). Age groups were: Toddler (2-4 years), Young pediatric (5-7 years), Pediatric (8-12 years), and Teens (13-18 years). Depending on the participant's age, the questionnaire may be completed by parent/caregiver as appropriate. For the Toddler group, the PedsQL GCS consisted of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consisted of 23 items, with a 3-point Likert scale (0, 2, 4) for the young pediatric, and a 5-point Likert scale for the pediatric and teens groups. Scores are transformed on a scale from 0 to 100 where 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.
Time Frame	Baseline, Last visit in NT (up to Month 39)

Outcome Measure Data

Analysis Population Description

Analysis was performed using safety population. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm/Group Title	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide /Non-teduglutide Treatment (TED/NTT)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	4	1	1	14
Physical Functioning: Change at Last NT	3.91 (10.636)	-3.13 (NA)	31.25 (NA)	13.56 (22.573)
Emotional Functioning: Change at Last NT	-2.50 (15.546)	-10.00 (NA)	0.00 (NA)	2.50 (23.101)
Social Functioning: Change at Last NT	0.00 (4.082)	-10.00 (NA)	-10.00 (NA)	7.31 (16.535)
School Functioning: Change at Last NT	11.67 (45.369)	0.00 (NA)	3.89 (25.954)

42. Other Pre-specified Outcome

Title	Change From Baseline In PedsQL Total Family Impact Module Score at EOT of Each Cycle During Teduglutide Treatment
Description	PedsQL Family Impact Module was composed of 36 items comprising Physical Functioning (6 items), Emotional Functioning (5 items), Social Functioning (4 items), Cognitive Functioning (5 items), Communication (3 items), Worry (5 items), Daily Activities (3 items) and Family Relationships (5 items). Total family impact score was calculated as the sum of all the items over the number of items answered on all the scales. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	43
Change at EOT of Cycle 1	-10.65 (9.326)	1.55 (15.071)
Change at EOT of Cycle 2	-2.78 (3.928)	4.62 (18.250)
Change at EOT of Cycle 3	-5.56 (5.893)	0.20 (20.861)
Change at EOT of Cycle 4	2.78 (NA)	5.27 (21.637)
Change at EOT of Cycle 5	-13.19 (NA)	5.08 (16.152)

43. Other Pre-specified Outcome

Title	Change From Baseline In PedsQL Total Family Impact Module Score at Last Visit During Non-Teduglutide Treatment (NT)
Description	PedsQL Family Impact Module was composed of 36 items comprising Physical Functioning (6 items), Emotional Functioning (5 items), Social Functioning (4 items), Cognitive Functioning (5 items), Communication (3 items), Worry (5 items), Daily Activities (3 items) and Family Relationships (5 items). Total family impact score was calculated as the sum of all the items over the number of items answered on all the scales. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life
Time Frame	Baseline, Last visit in NT (up to Month 39)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm/Group Title	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide /Non-teduglutide Treatment (TED/NTT)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	3	1	1	15
Mean (Standard Deviation) [Score on a scale]	-3.47 (10.914)	-27.78 (NA)	-12.50 (NA)	6.44 (22.648)

44. Other Pre-specified Outcome

Title	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment
Description	PedsQL Gastrointestinal symptoms module was composed of 58 items, comprised of 10 different symptom scales that assess gastrointestinal symptom-related quality of life: food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea. Only the scales of food and drink limits (6 items) and diarrhea (7 items) was used in this study. Sub-scale score was calculated as the sum of the items over the number of items answered in the scale. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.
Time Frame	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Outcome Measure Data

Analysis Population Description

The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm/Group Title	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	2	39
Food and Drink Limits: Change at EOT of Cycle 1	-12.50 (17.678)	1.71 (31.250)
Food and Drink Limits: Change at EOT of Cycle 2	-4.17 (NA)	9.41 (35.583)
Food and Drink Limits: Change at EOT of Cycle 3	-4.17 (NA)	11.83 (36.178)
Food and Drink Limits: Change at EOT of Cycle 4	12.50 (NA)	18.56 (33.227)
Food and Drink Limits: Change at EOT of Cycle 5	0.00 (NA)	13.33 (25.215)
Diarrhea: Change at EOT of Cycle 1	0.00 (NA)	8.56 (21.309)
Diarrhea: Change at EOT of Cycle 2	0.00 (NA)	10.00 (19.162)
Diarrhea: Change at EOT of Cycle 3	11.49 (23.665)
Diarrhea: Change at EOT of Cycle 4	-3.57 (NA)	8.57 (23.702)
Diarrhea: Change at EOT of Cycle 5	5.56 (27.147)

45. Other Pre-specified Outcome

Title	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at Last Visit During Non-Teduglutide Treatment (NT)
Description	PedsQL gastrointestinal symptoms module was composed of 58 items, comprised of 10 different symptom scales that assess gastrointestinal symptom-related quality of life: food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea. Only the scales of food and drink limits (6 items) and diarrhea (7 items) was used in this study. Sub-scale score was calculated as the sum of the items over the number of items answered in the scale. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.
Time Frame	Baseline, Last visit in NT (up to Month 39)

Outcome Measure Data

Analysis Population Description

Analysis was performed using safety population. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm/Group Title	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide /Non-teduglutide Treatment (TED/NTT)	Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
Measure Participants	4	1	1	12
Food and Drink Limits: Change at Last NT	-7.29 (32.698)	-29.17 (NA)	-8.33 (NA)	5.35 (34.013)
Diarrhea: Change at Last NT	-4.46 (4.494)	3.57 (NA)	1.70 (19.555)

Adverse Events

Time Frame	From start of study drug administration up to follow-up (up to 46 months)
Arm/Group Title	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)		Non-teduglutide/Teduglutide Treatment (NTT/TED)		Teduglutide /Non-teduglutide Treatment (TED/NTT)		Teduglutide/Teduglutide Treatment (TED/TED)
Arm/Group Description	Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.		Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.		Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.		Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
All Cause Mortality
	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)		Non-teduglutide/Teduglutide Treatment (NTT/TED)		Teduglutide /Non-teduglutide Treatment (TED/NTT)		Teduglutide/Teduglutide Treatment (TED/TED)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/3 (0%)		0/1 (0%)		2/50 (4%)
Serious Adverse Events
	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)		Non-teduglutide/Teduglutide Treatment (NTT/TED)		Teduglutide /Non-teduglutide Treatment (TED/NTT)		Teduglutide/Teduglutide Treatment (TED/TED)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/7 (57.1%)		2/3 (66.7%)		1/1 (100%)		41/50 (82%)
Cardiac disorders
Atrial thrombosis	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Gastrointestinal disorders
Abdominal distension	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Abdominal pain	0/7 (0%)	0	1/3 (33.3%)	2	0/1 (0%)	0	1/50 (2%)	1
Colitis	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	0/50 (0%)	0
Colonic haematoma	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Diarrhoea	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	2/50 (4%)	2
Enterocutaneous fistula	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Faecaloma	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Gastrointestinal haemorrhage	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Haematochezia	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Ileus	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Ileus paralytic	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	0/50 (0%)	0
Intestinal dilatation	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	0/50 (0%)	0
Mallory-Weiss syndrome	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Small intestinal stenosis	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	0/50 (0%)	0
Vomiting	0/7 (0%)	0	1/3 (33.3%)	2	0/1 (0%)	0	2/50 (4%)	3
General disorders
Complication associated with device	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	1/50 (2%)	1
Condition aggravated	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Granuloma	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Pyrexia	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	16/50 (32%)	31
Hepatobiliary disorders
Cholangitis	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Cholelithiasis	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	2/50 (4%)	2
Immune system disorders
Anaphylactic reaction	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Infections and infestations
Adenovirus infection	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Arthritis viral	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Bacteraemia	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Catheter site infection	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Cellulitis	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	2/50 (4%)	2
Clostridium difficile colitis	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	2
Clostridium difficile infection	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Croup infectious	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	2
Cystitis	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Device related infection	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	15/50 (30%)	25
Device related sepsis	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	4/50 (8%)	4
Escherichia bacteraemia	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Gastroenteritis	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Gastroenteritis astroviral	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Gastroenteritis clostridial	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Gastroenteritis viral	2/7 (28.6%)	2	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Gastrointestinal bacterial overgrowth	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Hand-foot-and-mouth disease	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Infectious mononucleosis	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Influenza	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	6/50 (12%)	6
Lower respiratory tract infection	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Malassezia infection	1/7 (14.3%)	2	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Overgrowth bacterial	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	0/50 (0%)	0
Pharyngitis streptococcal	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Pneumonia	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Pneumonia viral	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Pulmonary mycosis	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Respiratory syncytial virus infection	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	2
Rhinovirus infection	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	1/50 (2%)	1
Rotavirus infection	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	0/50 (0%)	0
Sepsis	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	2/50 (4%)	2
Septic shock	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Staphylococcal bacteraemia	2/7 (28.6%)	3	1/3 (33.3%)	2	0/1 (0%)	0	0/50 (0%)	0
Staphylococcal infection	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	2
Staphylococcal sepsis	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Upper respiratory tract infection	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	2/50 (4%)	2
Urinary tract infection	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	3
Viral infection	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	2/50 (4%)	2
Viral upper respiratory tract infection	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Injury, poisoning and procedural complications
Abdominal wound dehiscence	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Femur fracture	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	2/50 (4%)	3
Postoperative ileus	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Procedural haemorrhage	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Vascular access complication	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Investigations
Astrovirus test positive	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	0/50 (0%)	0
Bacterial test positive	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Blood bilirubin increased	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Blood culture positive	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Enterovirus test positive	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Escherichia test positive	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	2
Haemoglobin decreased	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Metabolism and nutrition disorders
Acidosis	1/7 (14.3%)	5	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	2
Dehydration	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	2/50 (4%)	7
Failure to thrive	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Feeding intolerance	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	2/50 (4%)	2
Hyperchloraemia	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Hypernatraemia	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Hypokalaemia	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Hyponatraemia	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	2
Lactic acidosis	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	2
Metabolic acidosis	0/7 (0%)	0	0/3 (0%)	0	1/1 (100%)	4	4/50 (8%)	4
Musculoskeletal and connective tissue disorders
Arthralgia	0/7 (0%)	0	0/3 (0%)	0	1/1 (100%)	1	0/50 (0%)	0
Tenosynovitis	0/7 (0%)	0	0/3 (0%)	0	1/1 (100%)	1	0/50 (0%)	0
Nervous system disorders
Cerebral ischaemia	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Ischaemic stroke	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	2
Lethargy	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Seizure	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	2
Product Issues
Device breakage	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	5/50 (10%)	6
Device dislocation	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	2/50 (4%)	2
Device expulsion	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Device malfunction	1/7 (14.3%)	2	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Device occlusion	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	3
Psychiatric disorders
Mental status changes	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Renal and urinary disorders
Nephrolithiasis	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Renal tubular acidosis	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Tubulointerstitial nephritis	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	2
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Cough	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Hypocapnia	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	2
Respiratory failure	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Vascular disorders
Superior vena cava occlusion	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Vena cava thrombosis	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Other (Not Including Serious) Adverse Events
	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)		Non-teduglutide/Teduglutide Treatment (NTT/TED)		Teduglutide /Non-teduglutide Treatment (TED/NTT)		Teduglutide/Teduglutide Treatment (TED/TED)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/7 (85.7%)		3/3 (100%)		1/1 (100%)		50/50 (100%)
Blood and lymphatic system disorders
Anaemia	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	2/50 (4%)	4
Coagulopathy	0/7 (0%)	0	0/3 (0%)	0	1/1 (100%)	1	2/50 (4%)	2
Lymphadenopathy	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	4/50 (8%)	5
Cardiac disorders
Tachycardia	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	3
Ear and labyrinth disorders
Ear pain	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	4
Eye disorders
Dry eye	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Gastrointestinal disorders
Abdominal distension	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	6/50 (12%)	6
Abdominal pain	1/7 (14.3%)	4	1/3 (33.3%)	1	0/1 (0%)	0	15/50 (30%)	33
Abdominal pain upper	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	7/50 (14%)	10
Abnormal faeces	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Anal incontinence	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Colitis	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	0/50 (0%)	0
Constipation	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	3
Diarrhoea	1/7 (14.3%)	1	1/3 (33.3%)	2	0/1 (0%)	0	14/50 (28%)	29
Enteritis	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Flatulence	1/7 (14.3%)	2	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	3
Frequent bowel movements	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	2/50 (4%)	2
Gastrointestinal haemorrhage	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	0/50 (0%)	0
Haematochezia	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	4/50 (8%)	6
Nausea	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	7/50 (14%)	7
Toothache	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	0/50 (0%)	0
Vomiting	4/7 (57.1%)	12	3/3 (100%)	11	1/1 (100%)	1	25/50 (50%)	77
General disorders
Catheter site discharge	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Catheter site extravasation	2/7 (28.6%)	2	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Catheter site haemorrhage	2/7 (28.6%)	2	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Complication associated with device	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	0/50 (0%)	0
Fatigue	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	8/50 (16%)	9
Influenza like illness	0/7 (0%)	0	0/3 (0%)	0	1/1 (100%)	1	0/50 (0%)	0
Medical device site pain	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	0/50 (0%)	0
Pyrexia	2/7 (28.6%)	2	1/3 (33.3%)	1	1/1 (100%)	1	16/50 (32%)	21
Thirst	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Hepatobiliary disorders
Drug-induced liver injury	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Infections and infestations
Device related infection	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	4
Ear infection	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	5/50 (10%)	5
Gastroenteritis viral	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	4
Gastrointestinal bacterial overgrowth	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	4/50 (8%)	7
Influenza	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	5/50 (10%)	8
Malassezia infection	1/7 (14.3%)	2	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Nasopharyngitis	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	9/50 (18%)	15
Otitis media	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	4
Otitis media acute	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	5
Respiratory tract infection	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	4/50 (8%)	4
Rhinitis	0/7 (0%)	0	1/3 (33.3%)	1	1/1 (100%)	1	5/50 (10%)	9
Staphylococcal sepsis	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Upper respiratory tract infection	3/7 (42.9%)	5	1/3 (33.3%)	1	0/1 (0%)	0	15/50 (30%)	41
Urinary tract infection	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	15
Varicella	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	2/50 (4%)	2
Viral infection	1/7 (14.3%)	2	1/3 (33.3%)	2	0/1 (0%)	0	9/50 (18%)	13
Viral upper respiratory tract infection	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	4/50 (8%)	5
Injury, poisoning and procedural complications
Abdominal wound dehiscence	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Anastomotic ulcer	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	4
Contusion	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	5/50 (10%)	11
Fall	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Gastrointestinal stoma complication	0/7 (0%)	0	1/3 (33.3%)	2	0/1 (0%)	0	2/50 (4%)	2
Gastrostomy tube site complication	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	4/50 (8%)	6
Laceration	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	4/50 (8%)	4
Ligament sprain	1/7 (14.3%)	2	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Post procedural discomfort	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Procedural pain	2/7 (28.6%)	3	1/3 (33.3%)	1	0/1 (0%)	0	0/50 (0%)	0
Skin abrasion	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	4/50 (8%)	6
Soft tissue injury	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Stoma site reaction	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	2/50 (4%)	3
Investigations
Alanine aminotransferase increased	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	10/50 (20%)	16
Aspartate aminotransferase increased	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	4/50 (8%)	4
Blood 25-hydroxycholecalciferol increased	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Blood bicarbonate decreased	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	4/50 (8%)	4
Blood bicarbonate increased	0/7 (0%)	0	0/3 (0%)	0	1/1 (100%)	1	0/50 (0%)	0
Blood creatinine increased	1/7 (14.3%)	1	1/3 (33.3%)	1	0/1 (0%)	0	1/50 (2%)	1
Blood triglycerides increased	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	0/50 (0%)	0
Blood urea increased	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	4/50 (8%)	4
Blood urine present	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	3
Body temperature increased	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	3
C-reactive protein increased	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	8/50 (16%)	9
Carcinoembryonic antigen increased	0/7 (0%)	0	0/3 (0%)	0	1/1 (100%)	1	0/50 (0%)	0
Crystal urine present	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	3
Gamma-glutamyltransferase increased	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	4/50 (8%)	6
Gastrointestinal stoma output increased	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	2/50 (4%)	3
Haemoglobin decreased	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	4/50 (8%)	4
International normalised ratio increased	0/7 (0%)	0	0/3 (0%)	0	1/1 (100%)	2	3/50 (6%)	4
Lipase increased	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	4/50 (8%)	4
Prothrombin time prolonged	0/7 (0%)	0	0/3 (0%)	0	1/1 (100%)	2	3/50 (6%)	4
Transaminases increased	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	1/50 (2%)	1
White blood cells urine positive	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	3
Metabolism and nutrition disorders
Acidosis	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	3
Decreased appetite	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	5/50 (10%)	5
Dehydration	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	4
Hyperchloraemia	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	3
Hypoglycaemia	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	2/50 (4%)	2
Hypokalaemia	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	4/50 (8%)	7
Hyponatraemia	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	3
Metabolic acidosis	0/7 (0%)	0	0/3 (0%)	0	1/1 (100%)	1	5/50 (10%)	6
Musculoskeletal and connective tissue disorders
Pain in extremity	0/7 (0%)	0	0/3 (0%)	0	1/1 (100%)	1	5/50 (10%)	7
Tenosynovitis	0/7 (0%)	0	0/3 (0%)	0	1/1 (100%)	1	0/50 (0%)	0
Nervous system disorders
Dizziness	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	4/50 (8%)	4
Headache	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	11/50 (22%)	24
Lethargy	1/7 (14.3%)	3	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	5
Product Issues
Device breakage	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	7/50 (14%)	12
Device malfunction	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	2/50 (4%)	4
Device occlusion	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	5/50 (10%)	8
Psychiatric disorders
Learning disability	0/7 (0%)	0	0/3 (0%)	0	1/1 (100%)	1	0/50 (0%)	0
Renal and urinary disorders
Haematuria	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	3/50 (6%)	4
Nephrolithiasis	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Respiratory, thoracic and mediastinal disorders
Bronchospasm	0/7 (0%)	0	0/3 (0%)	0	1/1 (100%)	1	0/50 (0%)	0
Cough	1/7 (14.3%)	1	2/3 (66.7%)	3	0/1 (0%)	0	16/50 (32%)	41
Epistaxis	1/7 (14.3%)	2	1/3 (33.3%)	2	0/1 (0%)	0	2/50 (4%)	10
Nasal congestion	0/7 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	7/50 (14%)	11
Oropharyngeal pain	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	5/50 (10%)	6
Rhinitis allergic	1/7 (14.3%)	2	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Rhinorrhoea	1/7 (14.3%)	1	1/3 (33.3%)	2	0/1 (0%)	0	10/50 (20%)	26
Skin and subcutaneous tissue disorders
Erythema	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Pain of skin	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0	0/50 (0%)	0
Rash	1/7 (14.3%)	1	1/3 (33.3%)	2	1/1 (100%)	1	11/50 (22%)	20
Rash erythematous	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0
Rash papular	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	1/50 (2%)	1
Surgical and medical procedures
Catheter removal	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0	0/50 (0%)	0

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.