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Clinical Trial Results:
A Retrospective and Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Subjects with Short Bowel Syndrome Who Completed TED-C13-003

Summary
EudraCT number	2016-000863-17
Trial protocol	GB
Global end of trial date	14 Jul 2020

Results information
Results version number	v1(current)
This version publication date	29 Jan 2021
First version publication date	29 Jan 2021
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

SHP633-303

ISRCTN number

US NCT number

NCT02949362

WHO universal trial number (UTN)

Sponsor organisation name

Shire

Sponsor organisation address

300 ShireWay, Lexington, United States, MA 02421

Public contact

Study Director, Shire, +1 866 842 5335, ClinicalTransparency@shire.com

Scientific contact

Study Director, Shire, +1 866 842 5335, ClinicalTransparency@shire.com

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-000482-PIP01-08

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

14 Jul 2020

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

14 Jul 2020

Was the trial ended prematurely?

Main objective of the trial

The primary objective of the study is to evaluate the long-term safety and tolerability of teduglutide treatment in pediatric subjects with short bowel syndrome (SBS) who completed TED-C13-003 (2013-004588-30).

Protection of trial subjects

The study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki and in compliance with all applicable industry regulations, International Council For Harmonisation Good Clinical Practice Guideline E6 (1996), European Union Directive 2001/20/EC, as well as all applicable national and local laws and regulations.

Background therapy

Evidence for comparator

Actual start date of recruitment

09 Dec 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 26

Country: Number of subjects enrolled

United Kingdom: 3

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study was conducted at 11 sites in United Kingdom and United States between 09 December 2016 (first subject first visit) and 14 July 2020 (last subject last visit).

Screening details

Of the 40 subjects who completed TED-C13-003, 29 subjects consented to retrospective period. Of these, 24 enrolled into Retro TED/NTT (didn’t receive teduglutide) and 5 into Retro TED/TED (received teduglutide). Out of 29 subjects of retrospective period, 24 enrolled into prospective period (ANY TED group), including 19 in TED/TED and 5 in TED/NTT.

Period 1 title

Period 1: Retrospective Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Retrospective TED/NTT Group

Arm description

Subjects who received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous (SC) injection once daily in TED-C13-003 (2013-004588-30) and didn't received teduglutide in retrospective period of current study SHP633-303 (2016-000863-17).

Arm type

Experimental

Investigational medicinal product name

Teduglutide

Investigational medicinal product code

ALX-0600

Other name

Revestive

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received teduglutide 0.05 mg/kg SC injection once daily in TED-C13-003 (2013-004588-30) and didn't received in retrospective period of current study SHP633-303 (2016-000863-17).

Retrospective TED/TED Group

Arm description

Subjects who received teduglutide 0.05 mg/kg SC injection once daily in TED-C13-003 (2013-004588-30) and received teduglutide in retrospective period of current study SHP633-303 (2016-000863-17).

Arm type

Experimental

Investigational medicinal product name

Teduglutide

Investigational medicinal product code

ALX-0600

Other name

Revestive

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received teduglutide 0.05 mg/kg SC injection once daily in TED-C13-003 (2013-004588-30) and received in retrospective period of current study SHP633-303 (2016-000863-17).

Number of subjects in period 1	Retrospective TED/NTT Group	Retrospective TED/TED Group
Started	24	5
Completed	20	4
Not completed	4	1
Inform consent is not signed	4	1

Period 2 title

Period 2: Prospective Data

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Prospective TED/NTT Group

Arm description

Subjects who received teduglutide 0.05 mg/kg SC injection once daily in TED-C13-003 (2013-004588-30) and didn't received teduglutide in prospective period of current study SHP633-303 (2016-000863-17) up to 24 weeks.

Arm type

Experimental

Investigational medicinal product name

Teduglutide

Investigational medicinal product code

ALX-0600

Other name

Revestive

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received teduglutide 0.05 mg/kg SC injection once daily in TED-C13-003 (2013-004588-30) and didn't received in prospective period of current study SHP633-303 (2016-000863-17) up to 24 weeks.

Prospective TED/TED Group

Arm description

Subjects who received teduglutide 0.05 mg/kg SC injection once daily in TED-C13-003 (2013-004588-30) and also received teduglutide in prospective period of current study SHP633-303 (2016-000863-17) up to 24 weeks.

Arm type

Experimental

Investigational medicinal product name

Teduglutide

Investigational medicinal product code

ALX-0600

Other name

Revestive

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received teduglutide 0.05 mg/kg SC injection once daily in TED-C13-003 (2013-004588-30) and received in prospective period of current study SHP633-303 (2016-000863-17) up to 24 weeks.

Number of subjects in period 2	Prospective TED/NTT Group	Prospective TED/TED Group
Started	5	19
Completed	4	15
Not completed	1	4
subject didn't complete an early termination visit	1	-
Unspecified	-	4

Baseline characteristics

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Reporting group title

Retrospective TED/NTT Group

Reporting group description

Reporting group title

Retrospective TED/TED Group

Reporting group description

Subjects who received teduglutide 0.05 mg/kg SC injection once daily in TED-C13-003 (2013-004588-30) and received teduglutide in retrospective period of current study SHP633-303 (2016-000863-17).

Reporting group values	Retrospective TED/NTT Group	Retrospective TED/TED Group	Total
Number of subjects	24	5	29
Age Categorical
Units: Subjects
Age Continuous
Units: years
arithmetic mean (standard deviation)	4.0 ± 2.88	8.2 ± 5.50	-
Gender Categorical
Units: Subjects
Female	9	0	9
Male	15	5	20
Race (NIH/OMB)
Units: Subjects
White	20	3	23
Black or African American	2	1	3
Asian	0	1	1
Other	2	0	2
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	9	1	10
Not Hispanic or Latino	15	3	18
Not allowed based on local regulations	0	1	1

End points

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Reporting group title

Retrospective TED/NTT Group

Reporting group description

Reporting group title

Retrospective TED/TED Group

Reporting group description

Subjects who received teduglutide 0.05 mg/kg SC injection once daily in TED-C13-003 (2013-004588-30) and received teduglutide in retrospective period of current study SHP633-303 (2016-000863-17).

Reporting group title

Prospective TED/NTT Group

Reporting group description

Reporting group title

Prospective TED/TED Group

Reporting group description

Primary: Number of Subjects With Adverse Events (AEs), Related AEs, Serious Adverse Events (SAEs) and Related SAEs of Retrospective Observation Period

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End point title

Number of Subjects With Adverse Events (AEs), Related AEs, Serious Adverse Events (SAEs) and Related SAEs of Retrospective Observation Period ^[1]

End point 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. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, was an important medical event. Retrospective subjects (RETRO) are all subjects who consented to participation in this extension study and provided data for the retrospective period of the protocol.

End point type

Primary

End point timeframe

From end of the core study (TED-C13-003 [2013-004588-30]) up to end of the current study (up to 168 weeks)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical and comparison analyses were performed for this endpoint.

End point values	Retrospective TED/NTT Group	Retrospective TED/TED Group
Number of subjects analysed	24	5
Units: Subjects
Subjects with AEs	23	4
Subjects with Related AEs	23	4
Subjects with SAEs	23	4
Subjects with Related SAEs	0	0

No statistical analyses for this end point

Primary: Change From Baseline in Height for Age Z-score at Week 168 of Retrospective Observation Period

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End point title

Change From Baseline in Height for Age Z-score at Week 168 of Retrospective Observation Period ^[2]

End point description

Height was measured using age 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 greater than or equal to [>=] 2 years old) and World Health Organization (age less than [<] 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. Change from baseline in height for age Z-score at Week 168 of retrospective observation period was reported. Retrospective subjects (RETRO) are all subjects who consented to participation in this extension study and provided data for the retrospective period of the protocol. Here, the number of subjects analysed refer to the subjects evaluable for this timepoint.

End point type

Primary

End point timeframe

Baseline: From end of the core study (TED-C13-003 [2013-004588-30]), Week 168

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical and comparison analyses were performed for this endpoint.

End point values	Retrospective TED/NTT Group	Retrospective TED/TED Group
Number of subjects analysed	2	0 ^[3]
Units: Z-score
arithmetic mean (standard deviation)	0.128 ± 0.0505	±

Notes
[3] - Data for this end point was not planned to be collected and analysed in retrospective TED/TED group.

No statistical analyses for this end point

Primary: Change From Baseline in Body Weight for age Z-score at Week 168 of Retrospective Observation Period

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End point title

Change From Baseline in Body Weight for age Z-score at Week 168 of Retrospective Observation Period ^[4]

End point description

Body weight was measured using age 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. Change from baseline in body weight for age Z-score at Week 168 was reported. Retrospective subjects (RETRO) are all subjects who consented to participation in this extension study and provided data for the retrospective period of the protocol. Here, the number of subjects analysed refer to the subjects evaluable for this timepoint.

End point type

Primary

End point timeframe

Baseline: From end of the core study (TED-C13-003 [2013-004588-30]), Week 168

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical and comparison analyses were performed for this endpoint.

End point values	Retrospective TED/NTT Group	Retrospective TED/TED Group
Number of subjects analysed	2	0 ^[5]
Units: Z-score
arithmetic mean (standard deviation)	-0.181 ± 0.0601	±

Notes
[5] - Data for this end point was not planned to be collected and analysed in retrospective TED/TED group.

No statistical analyses for this end point

Primary: Change From Baseline in Head Circumference for Age Z-score at Week 12 of Retrospective Observation Period

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End point title

Change From Baseline in Head Circumference for Age Z-score at Week 12 of Retrospective Observation Period ^[6]

End point description

Head circumference was measured using age 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. Change from baseline in head circumference for age Z-score at Week 12 of retrospective observation period was reported. Retrospective subjects (RETRO) are all subjects who consented to participation in this extension study and provided data for the retrospective period of the protocol. Here, the number of subjects analysed refer to the subjects evaluable for this timepoint. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed for the specified arm.

End point type

Primary

End point timeframe

Baseline: From end of the core study (TED-C13-003 [2013-004588-30]), Week 12

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical and comparison analyses were performed for this endpoint.

End point values	Retrospective TED/NTT Group	Retrospective TED/TED Group
Number of subjects analysed	0 ^[7]	1
Units: Z-score
arithmetic mean (standard deviation)	±	-0.260 ± 99999

Notes
[7] - Data for this end point was not planned to be collected and analysed in retrospective TED/NTT group.

No statistical analyses for this end point

Primary: Change From Baseline in Body Mass Index (BMI) for Age Z-score at Week 168 of Retrospective Observation Period

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End point title

Change From Baseline in Body Mass Index (BMI) for Age Z-score at Week 168 of Retrospective Observation Period ^[8]

End point description

BMI z-score was calculated by using the retrospective 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. Change from baseline in height for age Z-score at Week 168 of retrospective observation period was reported. Retrospective subjects (RETRO) are all subjects who consented to participation in this extension study and provided data for the retrospective period of the protocol. Here, the number of subjects analysed refer to the subjects evaluable for this timepoint.

End point type

Primary

End point timeframe

Baseline: From end of the core study (TED-C13-003 [2013-004588-30]), Week 168

Notes
[8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical and comparison analyses were performed for this endpoint.

End point values	Retrospective TED/NTT Group	Retrospective TED/TED Group
Number of subjects analysed	2	0 ^[9]
Units: Z-score
arithmetic mean (standard deviation)	-0.283 ± 0.0646	±

Notes
[9] - Data for this end point was not planned to be collected and analysed in retrospective TED/TED group.

No statistical analyses for this end point

Primary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESI) of Prospective Study Period

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End point title

Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESI) of Prospective Study Period ^[10]

End point description

TEAEs are defined as AEs that started or worsened on or after the first dose of teduglutide treatment in the core study. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, was an important medical event. AESI was an TEAE or TESAE of scientific and medical concern specific to the sponsor’s product or program and for which ongoing monitoring and immediate notification by the investigator to the sponsor. Safety population included all enrolled subjects who provided informed consent for the prospective portion and met all the inclusion criteria.

End point type

Primary

End point timeframe

Baseline: From end of retrospective study period up to follow-up (Week 28)

Notes
[10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical and comparison analyses were performed for this endpoint.

End point values	Prospective TED/NTT Group	Prospective TED/TED Group
Number of subjects analysed	5	19
Units: Subjects
Subjects with TEAEs	4	19
Subjects with TESAEs	3	17
Subjects with AESI	0	0

No statistical analyses for this end point

Primary: Change From Baseline in Height for Age Z-score at Cycle 6 Week 12 During the End of Each Teduglutide Treatment Period of Prospective Study Period

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End point title

Change From Baseline in Height for Age Z-score at Cycle 6 Week 12 During the End of Each Teduglutide Treatment Period of Prospective Study Period ^[11]

End point description

Height was measured using age 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. Change from baseline in height for age Z-score at Cycle 6 Week 12 during the end of each teduglutide treatment period in prospective study period was reported. Safety population included all enrolled subjects who provided informed consent for the prospective portion and met all the inclusion criteria. Here, the number of subjects analysed refer to the subjects evaluable for this timepoint. Since baseline scores were unavailable for TED/NTT group, data was not analysed for this arm.

End point type

Primary

End point timeframe

Baseline: From end of retrospective study period, Cycle 6 Week 12

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical and comparison analyses were performed for this endpoint.

End point values	Prospective TED/TED Group
Number of subjects analysed	3
Units: Z-score
arithmetic mean (standard deviation)	0.05 ± 1.068

No statistical analyses for this end point

Primary: Change From Baseline in Body Weight for Age Z-score at Cycle 6 Week 24 During the End of Each Teduglutide Treatment Period of Prospective Study Period

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End point title

Change From Baseline in Body Weight for Age Z-score at Cycle 6 Week 24 During the End of Each Teduglutide Treatment Period of Prospective Study Period ^[12]

End point description

Body weight was measured using age 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. Change from baseline in body weight for age Z-score at Cycle 6 Week 24 during the end of each teduglutide treatment period of prospective study period was reported. Safety population analysis. Here, the number of subjects analysed refer to the subjects evaluable for this timepoint. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed for the specified arm. Since baseline scores were unavailable for TED/NTT group, data was not analysed for this arm.

End point type

Primary

End point timeframe

Baseline: From end of retrospective study period, Cycle 6 Week 24

Notes
[12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical and comparison analyses were performed for this endpoint.

End point values	Prospective TED/TED Group
Number of subjects analysed	1
Units: Z-score
arithmetic mean (standard deviation)	-0.66 ± 99999

No statistical analyses for this end point

Primary: Change From Baseline in Body Mass Index (BMI) for Age Z-score at Cycle 6 Week 12 During the End of Each Teduglutide Treatment Period of Prospective Study Period

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End point title

Change From Baseline in Body Mass Index (BMI) for Age Z-score at Cycle 6 Week 12 During the End of Each Teduglutide Treatment Period of Prospective Study Period ^[13]

End point 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. Change from baseline in BMI for age Z-score at Cycle 6 Week 12 during the end of each teduglutide treatment period of prospective study period was reported. Safety population included all enrolled subjects who provided informed consent for the prospective portion and met all the inclusion criteria. Here, the number of subjects analysed refer to the subjects evaluable for this timepoint. Since baseline scores were unavailable for TED/NTT group, data was not analysed for this arm.

End point type

Primary

End point timeframe

Baseline: From end of retrospective study period, Cycle 6 Week 12

Notes
[13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical and comparison analyses were performed for this endpoint.

End point values	Prospective TED/TED Group
Number of subjects analysed	3
Units: Z-score
arithmetic mean (standard deviation)	-0.68 ± 0.349

No statistical analyses for this end point

Primary: Average Total 48-Hour Urine Output at Cycle 6 Week 12 During the End of Each Teduglutide Treatment Period of Prospective Study Period

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End point title

Average Total 48-Hour Urine Output at Cycle 6 Week 12 During the End of Each Teduglutide Treatment Period of Prospective Study Period ^[14]

End point description

Average total urine output was calculated based on the daily data recorded in subjects’ diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average total 48-Hour urine output at cycle 6 week 12 during the end of each teduglutide treatment period of prospective study period was reported. Safety population included all enrolled subjects who provided informed consent for the prospective portion and met all the inclusion criteria. Here, mL/kg/day is abbreviated as milliliter per kilogram per day. Here, the number of subjects analysed refer to the subjects evaluable for this time point. Since baseline scores were unavailable for TED/NTT group, data was not analysed for this arm.

End point type

Primary

End point timeframe

Baseline: From end of retrospective study period, Cycle 6 Week 12

Notes
[14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical and comparison analyses were performed for this endpoint.

End point values	Prospective TED/TED Group
Number of subjects analysed	3
Units: mL/kg/day
arithmetic mean (standard deviation)	14.38 ± 12.712

No statistical analyses for this end point

Primary: Average Total 48-Hour Urine Output at End of Study (EOS) During the End of Non-Teduglutide Treatment (NTT) Period of Prospective Study Period

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End point title

Average Total 48-Hour Urine Output at End of Study (EOS) During the End of Non-Teduglutide Treatment (NTT) Period of Prospective Study Period ^[15]

End point description

Average total urine output was calculated based on the daily data recorded in subjects’ diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average total 48-Hour urine output at EOS during the end of NTT period in prospective study period was reported. Safety population included all enrolled subjects who provided informed consent for the prospective portion and met all the inclusion criteria. Here, the number of subjects analysed refer to the subjects evaluable for this timepoint.

End point type

Primary

End point timeframe

Baseline: From end of retrospective study period, EOS (up to Week 28)

Notes
[15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical and comparison analyses were performed for this endpoint.

End point values	Prospective TED/NTT Group	Prospective TED/TED Group
Number of subjects analysed	2	0 ^[16]
Units: mL/kg/day
arithmetic mean (standard deviation)	22.86 ± 9.956	±

Notes
[16] - Data for this end point was not planned to be collected and analysed in prospective TED/TED group.

No statistical analyses for this end point

Primary: Average Number of Stools per Day at Cycle 6 Week 24 During the End of Each Teduglutide Treatment Period of Prospective Study Period

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End point title

Average Number of Stools per Day at Cycle 6 Week 24 During the End of Each Teduglutide Treatment Period of Prospective Study Period ^[17]

End point description

Average number of stools per day was calculated based on the daily data recorded in subjects’ diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average number of stools per day at cycle 6 week 24 during the end of each teduglutide treatment period in prospective study period was reported. Safety population included all enrolled subjects who provided informed consent for the prospective portion and met all the inclusion criteria. Here, the number of subjects analysed refer to the subjects evaluable for this timepoint. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed for the specified arm. Since baseline scores were unavailable for TED/NTT group, data was not analysed for this arm.

End point type

Primary

End point timeframe

Baseline: From end of retrospective study period, Cycle 6 Week 24

Notes
[17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical and comparison analyses were performed for this endpoint.

End point values	Prospective TED/TED Group
Number of subjects analysed	1
Units: Stools per day
arithmetic mean (standard deviation)	5.50 ± 99999

No statistical analyses for this end point

Primary: Average Number of Stools per Day at End of Study (EOS) During the End of Non-Teduglutide Treatment (NTT) Period of Prospective Study Period

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End point title

Average Number of Stools per Day at End of Study (EOS) During the End of Non-Teduglutide Treatment (NTT) Period of Prospective Study Period ^[18]

End point description

Average number of stools per day was calculated based on the daily data recorded in subjects’ diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average number of stools per day at EOS during the end of each teduglutide treatment period in prospective study period was reported. Safety population included all enrolled subjects who provided informed consent for the prospective portion and met all the inclusion criteria. Here, the number of subjects analysed refer to the subjects evaluable for this timepoint.

End point type

Primary

End point timeframe

Baseline: From end of retrospective study period, EOS (up to Week 28)

Notes
[18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical and comparison analyses were performed for this endpoint.

End point values	Prospective TED/NTT Group	Prospective TED/TED Group
Number of subjects analysed	2	0 ^[19]
Units: Stools per day
arithmetic mean (standard deviation)	3.75 ± 3.182	±

Notes
[19] - Data for this end point was not planned to be collected and analysed in prospective TED/TED group.

No statistical analyses for this end point

Primary: Number of Subjects With Positive Specific Antibodies at End of Study (EOS) During the End of Each Teduglutide Treatment Period of Prospective Study Period

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End point title

Number of Subjects With Positive Specific Antibodies at End of Study (EOS) During the End of Each Teduglutide Treatment Period of Prospective Study Period ^[20]

End point description

Number of subjects with positive specific antibodies to teduglutide were used to summarize the presence of antibodies. Safety population included all enrolled subjects who provided informed consent for the prospective portion and met all the inclusion criteria. Here, the number of subjects analysed refer to the subjects evaluable for this timepoint. Since baseline scores were unavailable for TED/NTT group, data was not analysed for this arm.

End point type

Primary

End point timeframe

Baseline: From end of retrospective study period, EOS (up to Week 28)

Notes
[20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical and comparison analyses were performed for this endpoint.

End point values	Prospective TED/TED Group
Number of subjects analysed	7
Units: Subjects	1

No statistical analyses for this end point

Secondary: Number of Participants Achieved At least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

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End point title

Number of Participants Achieved At least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

End point description

Number of participants achieved at least 20% reduction in PS volume at 12 weeks interval up to Week 156 in retrospective observation period was reported. Retrospective subjects (RETRO) are all subjects who consented to participation in this extension study and provided data for the retrospective portion of the protocol. Here, n=number of subjects analysed refer to the subjects evaluable for this timepoints.

End point type

Secondary

End point timeframe

Baseline: From end of the core study (TED-C13-003 [2013-004588-30]) at 12 weeks interval up to Week 156

End point values	Retrospective TED/NTT Group	Retrospective TED/TED Group
Number of subjects analysed	24	5
Units: Subjects
at 12 weeks (n=24, 5)	12	2
at 24 weeks (n=23, 5)	9	2
at 36 weeks (n=24, 4)	9	4
at 48 weeks (n=23, 4)	9	4
at 60 weeks (n=23, 5)	9	4
at 72 weeks (n=22, 5)	6	2
at 84 weeks (n=22, 5)	7	2
at 96 weeks (n=24, 5)	10	5
at 108 weeks (n=24, 5)	9	5
at 120 weeks (n=22, 5)	10	4
at 132 weeks (n=14, 4)	7	4
at 144 weeks (n=8, 1)	3	1
at 156 weeks (n=2, 1)	0	1

No statistical analyses for this end point

Secondary: Change From Baseline in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

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End point title

Change From Baseline in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

End point description

Change from baseline in PS volume at 12 weeks interval up to Week 156 in retrospective observation period was reported. Here, milliliter per kilogram per day is abbreviated as mL/kg/day. Retrospective subjects (RETRO) are all subjects who consented to participation in this extension study and provided data for the retrospective portion of the protocol. Here, n=number of subjects analysed refer to the subjects evaluable for this timepoints. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed for the specified arm.

End point type

Secondary

End point timeframe

Baseline: From end of the core study (TED-C13-003 [2013-004588-30]) at 12 weeks interval up to Week 156

End point values	Retrospective TED/NTT Group	Retrospective TED/TED Group
Number of subjects analysed	24	5
Units: mL/kg/day
arithmetic mean (standard deviation)
Change at 12 weeks (n=23, 5)	-14.45 ± 17.770	-12.84 ± 17.694
Change at 24 weeks (n=24, 4)	-9.27 ± 21.642	-13.49 ± 14.530
Change at 36 weeks (n=23, 5)	-10.65 ± 20.877	-17.91 ± 17.069
Change at 48 weeks (n=23, 4)	-12.24 ± 29.646	-26.12 ± 8.044
Change at 60 weeks (n=23, 5)	-13.85 ± 30.219	-21.35 ± 12.285
Change at 72 weeks (n=22, 5)	-13.65 ± 30.577	-11.41 ± 22.030
Change at 84 weeks (n=22, 5)	-8.74 ± 36.078	-15.65 ± 19.603
Change at 96 weeks (n=24, 5)	-12.87 ± 37.996	-27.34 ± 16.531
Change at 108 weeks (n=24, 5)	-10.35 ± 29.370	-31.83 ± 14.872
Change at 120 weeks (n=22, 5)	-12.21 ± 27.480	-30.48 ± 19.043
Change at 132 weeks (n=14, 4)	-19.20 ± 26.171	-37.70 ± 12.296
Change at 144 weeks (n=8, 1)	-16.79 ± 29.620	-34.32 ± 99999
Change at 156 weeks (n=2, 1)	-7.46 ± 1.931	-34.43 ± 99999

No statistical analyses for this end point

Secondary: Percent Change From Baseline in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

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End point title

Percent Change From Baseline in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

End point description

Percent change from baseline in PS volume at 12 weeks interval up to Week 156 of retrospective observation period was reported. Retrospective subjects (RETRO) are all subjects who consented to participation in this extension study and provided data for the retrospective portion of the protocol. Here, n=number of subjects analysed refer to the subjects evaluable for this timepoints. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed for the specified arm.

End point type

Secondary

End point timeframe

Baseline: From end of the core study (TED-C13-003 [2013-004588-30]) at 12 weeks interval up to Week 156

End point values	Retrospective TED/NTT Group	Retrospective TED/TED Group
Number of subjects analysed	24	5
Units: Percent change
arithmetic mean (standard deviation)
Percent change at 12 weeks (n=23, 5)	-24.50 ± 27.853	-24.88 ± 35.649
Percent change at 24 weeks (n=24, 4)	-10.72 ± 33.081	-32.10 ± 31.645
Percent change at 36 weeks (n=23, 5)	-13.21 ± 34.172	-43.09 ± 42.753
Percent change at 48 weeks (n=23, 4)	-14.04 ± 39.390	-65.18 ± 31.650
Percent change at 60 weeks (n=23, 5)	-16.15 ± 39.491	-53.61 ± 37.141
Percent change at 72 weeks (n=22, 5)	-14.19 ± 40.558	-14.11 ± 58.452
Percent change at 84 weeks (n=22, 5)	-8.67 ± 47.108	-30.25 ± 39.598
Percent change at 96 weeks (n=24, 5)	-12.04 ± 51.631	-61.19 ± 29.335
Percent change at 108 weeks (n=24, 5)	-10.62 ± 48.820	-73.43 ± 29.298
Percent change at 120 weeks (n=22, 5)	-12.89 ± 49.366	-69.61 ± 39.194
Percent change at 132 weeks (n=14, 4)	-20.24 ± 47.431	-85.92 ± 17.457
Percent change at 144 weeks (n=8, 1)	-7.70 ± 44.170	-65.20 ± 99999
Percent change at 156 weeks (n=2, 1)	-17.21 ± 3.164	-65.42 ± 99999

No statistical analyses for this end point

Secondary: Change From Baseline in Parenteral Support (PS) Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

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End point title

Change From Baseline in Parenteral Support (PS) Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

End point description

Change from baseline in PS caloric intake at 12 weeks interval up to Week 156 of retrospective observation period was reported. Here, kilo-calories per kilogram per day was abbreviated as (kcal/kg/day). Retrospective subjects (RETRO) are all subjects who consented to participation in this extension study and provided data for the retrospective portion of the protocol. Here, n=number of subjects analysed refer to the subjects evaluable for this timepoints. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed for the specified arm.

End point type

Secondary

End point timeframe

Baseline: From end of the core study (TED-C13-003 [2013-004588-30]) at 12 weeks interval up to Week 156

End point values	Retrospective TED/NTT Group	Retrospective TED/TED Group
Number of subjects analysed	24	5
Units: kcal/kg/day
arithmetic mean (standard deviation)
Change at 12 weeks (n=23, 5)	-10.15 ± 13.026	-2.64 ± 18.739
Change at 24 weeks (n=23, 4)	-3.96 ± 16.970	-7.25 ± 11.916
Change at 36 weeks (n=22, 5)	-8.38 ± 17.148	-6.42 ± 24.547
Change at 48 weeks (n=22, 4)	-9.84 ± 22.144	-18.11 ± 7.896
Change at 60 weeks (n=22, 5)	-10.55 ± 23.136	-10.53 ± 18.538
Change at 72 weeks (n=21, 5)	-12.64 ± 23.642	-0.05 ± 23.552
Change at 84 weeks (n=21, 5)	-9.70 ± 24.860	-5.24 ± 23.064
Change at 96 weeks (n=23, 5)	-10.08 ± 23.998	-15.09 ± 18.604
Change at 108 weeks (n=23, 5)	-7.20 ± 22.875	-19.05 ± 18.229
Change at 120 weeks (n=21, 5)	-7.98 ± 21.425	-17.18 ± 23.169
Change at 132 weeks (n=13, 4)	-12.93 ± 18.744	-27.59 ± 5.114
Change at 144 weeks (n=8, 1)	-11.97 ± 17.977	-25.53 ± 99999
Change at 156 weeks (n=2, 1)	-6.55 ± 4.708	-25.67 ± 99999

No statistical analyses for this end point

Secondary: Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

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End point title

Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

End point description

Percent change from baseline in PS caloric intake at 12 weeks interval up to Week 156 of retrospective observation period was reported. Retrospective subjects (RETRO) are all subjects who consented to participation in this extension study and provided data for the retrospective portion of the protocol. Here, n=number of subjects analysed refer to the subjects evaluable for this timepoints. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed for the specified arm.

End point type

Secondary

End point timeframe

Baseline: From end of the core study (TED-C13-003 [2013-004588-30]) at 12 weeks interval up to Week 156

End point values	Retrospective TED/NTT Group	Retrospective TED/TED Group
Number of subjects analysed	24	5
Units: Percent change
arithmetic mean (standard deviation)
Percent change at 12 weeks (n=23, 5)	-24.91 ± 29.001	7.64 ± 82.061
Percent change at 24 weeks (n=23, 4)	-10.12 ± 42.431	-21.29 ± 37.759
Percent change at 36 weeks (n=22, 5)	-18.29 ± 41.070	-3.38 ± 118.167
Percent change at 48 weeks (n=22, 4)	-21.03 ± 43.924	-59.31 ± 38.042
Percent change at 60 weeks (n=22, 5)	-20.63 ± 44.903	-25.65 ± 83.470
Percent change at 72 weeks (n=21, 5)	-25.48 ± 45.035	23.26 ± 99.380
Percent change at 84 weeks (n=21, 5)	-20.42 ± 45.287	4.41 ± 102.162
Percent change at 96 weeks (n=23, 5)	-21.12 ± 46.005	-36.49 ± 72.357
Percent change at 108 weeks (n=23, 5)	-16.41 ± 46.034	-50.24 ± 70.513
Percent change at 120 weeks (n=21, 5)	-18.79 ± 45.774	-38.58 ± 97.750
Percent change at 132 weeks (n=13, 4	-29.37 ± 40.170	-82.01 ± 21.165
Percent change at 144 weeks (n=8, 1)	-25.25 ± 33.618	-60.36 ± 99999
Percent change at 156 weeks (n=2, 1)	-15.66 ± 7.700	-60.69 ± 99999

No statistical analyses for this end point

Secondary: Change From Baseline in Number of Hours per Day of Parenteral Support (PS) Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

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End point title

Change From Baseline in Number of Hours per Day of Parenteral Support (PS) Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

End point description

Change from baseline were not presented as prescribed hours per day were not collected at baseline in the core study.

End point type

Secondary

End point timeframe

Baseline: From end of the core study (TED-C13-003 [2013-004588-30]) up to Week 156

End point values	Retrospective TED/NTT Group	Retrospective TED/TED Group
Number of subjects analysed	0 ^[21]	0 ^[22]
Units: Hours per day
arithmetic mean (standard deviation)	±	±

Notes
[21] - Data was not collected at baseline in the core study.
[22] - Data was not collected at baseline in the core study.

No statistical analyses for this end point

Secondary: Percent Change From Baseline in Number of Hours per Day of Parenteral Support (PS) Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

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End point title

Percent Change From Baseline in Number of Hours per Day of Parenteral Support (PS) Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

End point description

Percent changes from baseline was not presented as prescribed hours per day were not collected at baseline in the core study.

End point type

Secondary

End point timeframe

Baseline: From end of the core study (TED-C13-003 [2013-004588-30]) up to Week 156

End point values	Retrospective TED/NTT Group	Retrospective TED/TED Group
Number of subjects analysed	0 ^[23]	0 ^[24]
Units: Percent Change
arithmetic mean (standard deviation)	±	±

Notes
[23] - Data was not collected at baseline in the core study.
[24] - Data was not collected at baseline in the core study.

No statistical analyses for this end point

Secondary: Change From Baseline in Number of Days per Week of Parenteral Support (PS) Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

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End point title

Change From Baseline in Number of Days per Week of Parenteral Support (PS) Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

End point description

Change from baseline in number of days per Week of PS usage at 12 weeks interval up to Week 156 in retrospective observation period was reported. Retrospective subjects (RETRO) are all subjects who consented to participation in this extension study and provided data for the retrospective portion of the protocol. Here, n=number of subjects analysed refer to the subjects evaluable for this timepoints. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed for the specified arm.

End point type

Secondary

End point timeframe

Baseline: From end of the core study (TED-C13-003 [2013-004588-30]) at 12 weeks interval up to Week 156

End point values	Retrospective TED/NTT Group	Retrospective TED/TED Group
Number of subjects analysed	24	5
Units: Days per week
arithmetic mean (standard deviation)
Change at 12 weeks (n=24, 5)	-0.38 ± 1.469	-1.20 ± 2.683
Change at 24 weeks (n=24, 4)	-0.29 ± 1.429	-1.00 ± 2.000
Change at 36 weeks (n=23, 5)	-0.43 ± 1.562	-2.60 ± 2.793
Change at 48 weeks (n=23, 4)	-0.61 ± 2.017	-4.50 ± 2.082
Change at 60 weeks (n=23, 5)	-0.61 ± 2.017	-3.00 ± 3.536
Change at 72 weeks (n=22, 5)	-0.64 ± 2.060	-1.40 ± 2.966
Change at 84 weeks (n=22, 5)	-0.64 ± 2.060	-1.40 ± 2.966
Change at 96 weeks (n=24, 5)	-1.17 ± 2.665	-2.00 ± 3.536
Change at 108 weeks (n=24, 5)	-0.88 ± 2.365	-3.80 ± 3.701
Change at 120 weeks (n=22, 5)	-0.95 ± 2.459	-3.80 ± 3.701
Change at 132 weeks (n=14, 4)	-1.00 ± 2.542	-5.25 ± 2.062
Change at 144 weeks (n=8, 1)	0.00 ± 0.000	-3.00 ± 99999
Change at 156 weeks (n=2, 1)	0.00 ± 0.000	-3.00 ± 99999

No statistical analyses for this end point

Secondary: Percent Change From Baseline in Number of Days per Week of Parenteral Support (PS) Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

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End point title

Percent Change From Baseline in Number of Days per Week of Parenteral Support (PS) Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

End point description

Percent change from baseline in number of days per Week of PS usage at 12 weeks interval up to Week 156 in retrospective observation period was reported. Retrospective subjects (RETRO) are all subjects who consented to participation in this extension study and provided data for the retrospective portion of the protocol. Here, n=number of subjects analysed refer to the subjects evaluable for this timepoints. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed for the specified arm.

End point type

Secondary

End point timeframe

Baseline: From end of the core study (TED-C13-003 [2013-004588-30]) at 12 weeks interval up to Week 156

End point values	Retrospective TED/NTT Group	Retrospective TED/TED Group
Number of subjects analysed	24	5
Units: Percent change
arithmetic mean (standard deviation)
Percent change at 12 weeks (n=24, 5)	-6.25 ± 22.421	-14.86 ± 41.913
Percent change at 24 weeks (n=24, 4)	-4.17 ± 20.412	-14.29 ± 28.571
Percent change at 36 weeks (n=23, 5)	-6.21 ± 22.309	-34.86 ± 44.648
Percent change at 48 weeks (n=23, 4)	-8.70 ± 28.810	-64.29 ± 29.738
Percent change at 60 weeks (n=23, 5)	-8.70 ± 28.810	-40.57 ± 54.638
Percent change at 72 weeks (n=22, 5)	-9.09 ± 29.424	-17.71 ± 45.821
Percent change at 84 weeks (n=22, 5)	-9.09 ± 29.424	-17.71 ± 45.821
Percent change at 96 weeks (n=24, 5)	-16.67 ± 38.069	-26.29 ± 53.886
Percent change at 108 weeks (n=24, 5)	-12.50 ± 33.783	-52.00 ± 57.407
Percent change at 120 weeks (n=22, 5)	-13.64 ± 35.125	-52.00 ± 57.407
Percent change at 132 weeks (n=14, 4)	-14.29 ± 36.314	-75.00 ± 29.451
Percent change at 144 weeks (n=8, 1)	0.00 ± 0.000	-42.86 ± 99999
Percent change at 156 weeks (n=2, 1)	0.00 ± 0.000	-42.86 ± 99999

No statistical analyses for this end point

Secondary: Number of Participants Who Achieved At least 20, 50 and 75 Percent (%) Reduction in Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

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End point title

Number of Participants Who Achieved At least 20, 50 and 75 Percent (%) Reduction in Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

End point description

Number of participants who achieved at least 20, 50 and 75% reduction in PS volume at EOT of each cycle during the end of each teduglutide treatment period in prospective study period was reported. Safety population included all enrolled subjects who provided informed consent for the prospective portion and met all the inclusion criteria. Here, n=number of subjects analysed refer to the subjects evaluable for this endpoint at specific categories.

End point type

Secondary

End point timeframe

Baseline: From end of retrospective study period, EOT of each cycle (up to Week 24)

End point values	Prospective TED/TED Group
Number of subjects analysed	19
Units: Subjects
Cycle 1: EOT at >= 20% (n=19)	13
Cycle 2: EOT at >= 20% (n=17)	12
Cycle 3: EOT at >= 20% (n=14)	10
Cycle 4: EOT at >= 20% (n=13)	9
Cycle 5: EOT at >= 20% (n=8)	7
Cycle 6: EOT at >= 20% (n=5)	5
Cycle 1: EOT at >= 50% (n=19)	5
Cycle 2: EOT at >= 50% (n=17)	10
Cycle 3: EOT at >= 50% (n=14)	9
Cycle 4: EOT at >= 50% (n=13)	9
Cycle 5: EOT at >= 50% (n=8)	5
Cycle 6: EOT at >= 50% (n=5)	4
Cycle 1: EOT at >= 75% (n=19)	2
Cycle 2: EOT at >= 75% (n=17)	4
Cycle 3: EOT at >= 75% (n=14)	6
Cycle 4: EOT at >= 75% (n=13)	5
Cycle 5: EOT at >= 75% (n=8)	4
Cycle 6: EOT at >= 75% (n=5)	3

No statistical analyses for this end point

Secondary: Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

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End point title

Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

End point description

Change from baseline in PS volume at EOT of each cycle during the end of each teduglutide treatment period in prospective study period was reported. Safety population included all enrolled subjects who provided informed consent for the prospective portion and met all the inclusion criteria. Here, n=number of subjects analysed refer to the subjects evaluable for this endpoint at specific categories.

End point type

Secondary

End point timeframe

Baseline: From end of retrospective study period, EOT of each cycle (up to Week 24)

End point values	Prospective TED/TED Group
Number of subjects analysed	19
Units: mL/kg/day
arithmetic mean (standard deviation)
Cycle 1: EOT (n=18)	-25.18 ± 19.915
Cycle 2: EOT (n=16)	-28.59 ± 29.856
Cycle 3: EOT (n=13)	-40.05 ± 29.711
Cycle 4: EOT (n=12)	-40.10 ± 30.359
Cycle 5: EOT (n=7)	-40.49 ± 24.259
Cycle 6: EOT (n=5)	-47.57 ± 26.243

No statistical analyses for this end point

Secondary: Percent Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

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End point title

Percent Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

End point description

Percent change from baseline in PS volume at EOT of each cycle during the end of each teduglutide treatment period in prospective study period. Safety population included all enrolled subjects who provided informed consent for the prospective portion and met all the inclusion criteria. Here, n=number of subjects analysed refer to the subjects evaluable for this endpoint at specific categories.

End point type

Secondary

End point timeframe

Baseline: From end of retrospective study period, EOT of each cycle (up to Week 24)

End point values	Prospective TED/TED Group
Number of subjects analysed	19
Units: Percent Change
arithmetic mean (standard deviation)
Cycle 1: EOT (n=18)	-38.02 ± 28.611
Cycle 2: EOT (n=16)	-45.58 ± 48.150
Cycle 3: EOT (n=13)	-62.16 ± 41.805
Cycle 4: EOT (n=12)	-62.92 ± 38.466
Cycle 5: EOT (n=7)	-73.49 ± 34.593
Cycle 6: EOT (n=5)	-78.75 ± 33.949

No statistical analyses for this end point

Secondary: Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

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End point title

Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

End point description

Change from baseline in PS caloric intake at EOT of each cycle during the end of each teduglutide treatment period in prospective study period was reported. Safety population included all enrolled subjects who provided informed consent for the prospective portion and met all the inclusion criteria. Here, n=number of subjects analysed refer to the subjects evaluable for this endpoint at specific categories.

End point type

Secondary

End point timeframe

Baseline: From end of retrospective study period, EOT of each cycle (up to Week 24)

End point values	Prospective TED/TED Group
Number of subjects analysed	19
Units: kcal/kg/day
arithmetic mean (standard deviation)
Cycle 1: EOT (N= 19)	-17.66 ± 17.649
Cycle 2: EOT (n=17)	-19.95 ± 23.402
Cycle 3: EOT (n=14)	-27.66 ± 19.668
Cycle 4: EOT (n=13)	-24.05 ± 22.746
Cycle 5: EOT (n=8)	-26.98 ± 27.465
Cycle 6: EOT (n=5)	-27.53 ± 32.486

No statistical analyses for this end point

Secondary: Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

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End point title

Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

End point description

Percent change from baseline in PS caloric intake at EOT of each cycle during the end of each teduglutide treatment period in prospective study period was reported. Safety population included all enrolled subjects who provided informed consent for the prospective portion and met all the inclusion criteria. Here, n=number of subjects analysed refer to the subjects evaluable for this endpoint at specific categories.

End point type

Secondary

End point timeframe

Baseline: From end of retrospective study period, EOT of each cycle (up to Week 24)

End point values	Prospective TED/TED Group
Number of subjects analysed	19
Units: Percent change
arithmetic mean (standard deviation)
Cycle 1: EOT (n=19)	-33.50 ± 40.439
Cycle 2: EOT (n=17)	-42.06 ± 44.077
Cycle 3: EOT (n=14)	-62.47 ± 37.677
Cycle 4: EOT (n=13)	-49.51 ± 54.041
Cycle 5: EOT (n=8)	-54.08 ± 64.002
Cycle 6: EOT (n=5)	-59.00 ± 57.267

No statistical analyses for this end point

Secondary: Number of Subjects Who Achieved 100 Percent (%) Reduction in Complete Weaning of Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

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End point title

Number of Subjects Who Achieved 100 Percent (%) Reduction in Complete Weaning of Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

End point description

Number of subjects who achieved at least 100% reduction in complete weaning of PS volume at EOT of each cycle during the end of each teduglutide treatment period in prospective study period was reported. Safety population included all enrolled subjects who provided informed consent for the prospective portion and met all the inclusion criteria. Here, n=number of subjects analysed refer to the subjects evaluable for this endpoint at specific categories.

End point type

Secondary

End point timeframe

Baseline: From end of retrospective study period, EOT of each cycle (up to Week 24)

End point values	Prospective TED/TED Group
Number of subjects analysed	19
Units: Subjects
Cycle 1: EOT (n=19)	1
Cycle 2: EOT (n=17)	3
Cycle 3: EOT (n=14)	6
Cycle 4: EOT (n=13)	5
Cycle 5: EOT (n=8)	4
Cycle 6: EOT (n=5)	3

No statistical analyses for this end point

Secondary: Change From Baseline in Number of Hours per Day of Parenteral Support (PS) Usage at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

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End point title

Change From Baseline in Number of Hours per Day of Parenteral Support (PS) Usage at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

End point description

Change from baseline in number of hours per day of PS usage at EOT of each cycle during the end of each teduglutide treatment period in prospective study period was reported. Safety population included all enrolled subjects who provided informed consent for the prospective portion and met all the inclusion criteria. Here, n=number of subjects analysed refer to the subjects evaluable for this endpoint at specific categories.

End point type

Secondary

End point timeframe

Baseline: From end of retrospective study period, EOT of each cycle (up to Week 24)

End point values	Prospective TED/TED Group
Number of subjects analysed	19
Units: Hours per day
arithmetic mean (standard deviation)
Cycle 1: EOT (n=18)	-3.40 ± 3.752
Cycle 2: EOT (n=16)	-4.80 ± 5.360
Cycle 3: EOT (n=13)	-6.69 ± 4.247
Cycle 4: EOT (n=12)	-6.48 ± 4.881
Cycle 5: EOT (n=7)	-6.71 ± 6.175
Cycle 6: EOT (n=5)	-8.08 ± 6.075

No statistical analyses for this end point

Secondary: Percent Change From Baseline in Number of Hours per Day of Parenteral Support (PS) Usage at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

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End point title

Percent Change From Baseline in Number of Hours per Day of Parenteral Support (PS) Usage at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

End point description

Percent change from baseline in number of hours per day of PS usage at EOT of each cycle during the end of each teduglutide treatment period in prospective study period was reported. Safety population included all enrolled subjects who provided informed consent for the prospective portion and met all the inclusion criteria. Here, n=number of subjects analysed refer to the subjects evaluable for this endpoint at specific categories.

End point type

Secondary

End point timeframe

Baseline: From end of retrospective study period, EOT of each cycle (up to Week 24)

End point values	Prospective TED/TED Group
Number of subjects analysed	19
Units: Percent change
arithmetic mean (standard deviation)
Cycle 1: EOT (n=18)	-26.32 ± 29.732
Cycle 2: EOT (n=16)	-40.47 ± 40.476
Cycle 3: EOT (n=13)	-57.61 ± 36.973
Cycle 4: EOT (n=12)	-55.87 ± 42.693
Cycle 5: EOT (n=7)	-58.85 ± 52.717
Cycle 6: EOT (n=5)	-66.39 ± 46.042

No statistical analyses for this end point

Secondary: Change From Baseline in Number of Days per Week of Parenteral Support (PS) Usage at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

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End point title

Change From Baseline in Number of Days per Week of Parenteral Support (PS) Usage at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

End point description

Change from baseline in number of days per week of PS usage at EOT of each cycle during the end of each teduglutide treatment period in prospective study period was reported. Safety population included all enrolled subjects who provided informed consent for the prospective portion and met all the inclusion criteria. Here, n=number of subjects analysed refer to the subjects evaluable for this endpoint at specific categories.

End point type

Secondary

End point timeframe

Baseline: From end of retrospective study period, EOT of each cycle (up to Week 24)

End point values	Prospective TED/TED Group
Number of subjects analysed	19
Units: Days per week
arithmetic mean (standard deviation)
Cycle 1: EOT (n=18)	-0.60 ± 1.892
Cycle 2: EOT (n=16)	-1.93 ± 2.840
Cycle 3: EOT (n=13)	-3.03 ± 3.257
Cycle 4: EOT (n=12)	-2.99 ± 3.610
Cycle 5: EOT (n=7)	-3.83 ± 3.969
Cycle 6: EOT (n=5)	-4.37 ± 3.618

No statistical analyses for this end point

Secondary: Percent Change From Baseline in Number of Days per Week of Parenteral Support (PS) Usage at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

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End point title

Percent Change From Baseline in Number of Days per Week of Parenteral Support (PS) Usage at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

End point description

Percent change from baseline in number of days per week of PS usage at EOT of each cycle during the end of each teduglutide treatment period in prospective study period was reported. Safety population included all enrolled subjects who provided informed consent for the prospective portion and met all the inclusion criteria. Here, n=number of subjects analysed refer to the subjects evaluable for this endpoint at specific categories.

End point type

Secondary

End point timeframe

Baseline: From end of retrospective study period, EOT of each cycle (up to Week 24)

End point values	Prospective TED/TED Group
Number of subjects analysed	19
Units: Percent change
arithmetic mean (standard deviation)
Cycle 1: EOT (n=18)	-9.01 ± 27.472
Cycle 2: EOT (n=16)	-29.24 ± 40.525
Cycle 3: EOT (n=13)	-44.51 ± 47.929
Cycle 4: EOT (n=12)	-42.38 ± 51.929
Cycle 5: EOT (n=7)	-54.29 ± 57.404
Cycle 6: EOT (n=5)	-62.86 ± 51.110

No statistical analyses for this end point

Other pre-specified: Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

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End point title

Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

End point description

PedsQL GCS was used for quality of life assessment. It encompasses 4 dimensions of functioning (physical, emotional, social, school). Age groups are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Teens (13-18 years). Depending on the subject’s age, the questionnaire may be completed by either the subject or the parent/caregiver as appropriate. For the Toddler group, the PedsQL GCS consists of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consists of 23 items, with a 3-point Likert scale (0, 2, 4) for the young child, and a 5-point Likert scale for the child 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. Safety population analysis. Here, n=number of subjects analysed refer to subjects evaluable for this category. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed.

End point type

Other pre-specified

End point timeframe

Baseline: From end of retrospective study period, Week 12 and 24 of each treatment cycle

End point values	Prospective TED/TED Group
Number of subjects analysed	19
Units: Score on a scale
arithmetic mean (standard deviation)
Physical Functioning: Cycle1 Week12 (n=15)	-0.39 ± 24.326
Physical Functioning: Cycle1 Week24 (n=15)	-0.83 ± 10.726
Physical Functioning: Cycle2 Week12 (n=12)	2.34 ± 15.717
Physical Functioning: Cycle2 Week24 (n=13)	2.40 ± 16.296
Physical Functioning: Cycle3 Week12 (n=11)	-0.57 ± 16.167
Physical Functioning: Cycle3 Week24 (n=9)	-1.74 ± 25.963
Physical Functioning: Cycle4 Week12 (n=9)	-1.74 ± 22.378
Physical Functioning: Cycle4 Week24 (n=7)	1.79 ± 19.998
Physical Functioning: Cycle5 Week12 (n=5)	-7.50 ± 19.961
Physical Functioning: Cycle5 Week24 (n=4)	-2.34 ± 14.292
Physical Functioning: Cycle6 Week12 (n=4)	-6.25 ± 22.244
Physical Functioning: Cycle6 Week24 (n=1)	3.13 ± 99999
Emotional Functioning: Cycle1 Week12 (n=15)	4.17 ± 18.843
Emotional Functioning: Cycle1 Week24 (n=15)	-4.67 ± 24.511
Emotional Functioning: Cycle2 Week12 (n=12)	-3.33 ± 28.591
Emotional Functioning: Cycle2 Week24 (n=13)	-0.38 ± 21.454
Emotional Functioning: Cycle3 Week12 (n=11)	7.05 ± 29.661
Emotional Functioning: Cycle3 Week24 (n=9)	-8.33 ± 36.120
Emotional Functioning: Cycle4 Week12 (n=9)	2.78 ± 33.481
Emotional Functioning: Cycle4 Week24 (n=7)	-0.71 ± 35.786
Emotional Functioning: Cycle5 Week12 (n=5)	-11.00 ± 40.566
Emotional Functioning: Cycle5 Week24 (n=4)	-17.50 ± 37.804
Emotional Functioning: Cycle6 Week12 (n=4)	-5.63 ± 56.065
Emotional Functioning: Cycle6 Week24 (n=1)	17.50 ± 99999
Social Functioning: Cycle1 Week12 (n=1)	-15.00 ± 99999
Social Functioning: Cycle1 Week24 (n=1)	-10.00 ± 99999
Social Functioning: Cycle2 Week12 (n=1)	-5.00 ± 99999
Social Functioning: Cycle2 Week24 (n=1)	0.00 ± 99999
Social Functioning: Cycle3 Week12 (n=1)	10.00 ± 99999
Social Functioning: Cycle3 Week24 (n=1)	0.00 ± 99999
Social Functioning: Cycle4 Week12 (n=1)	10.00 ± 99999
Social Functioning: Cycle4 Week24 (n=1)	10.00 ± 99999
Social Functioning: Cycle5 Week12 (n=1)	10.00 ± 99999
Social Functioning: Cycle5 Week24 (n=1)	10.00 ± 99999
Social Functioning: Cycle6 Week12 (n=1)	10.00 ± 99999
Social Functioning: Cycle6 Week24 (n=0)	88888 ± 88888
School Functioning: Cycle1 Week12 (n=15)	5.67 ± 19.445
School Functioning: Cycle1 Week24 (n=15)	2.00 ± 20.160
School Functioning: Cycle2 Week12 (n=12)	-5.00 ± 24.027
School Functioning: Cycle2 Week24 (n=12)	8.75 ± 16.394
School Functioning: Cycle3 Week12 (n=11)	3.64 ± 23.355
School Functioning: Cycle3 Week24 (n=9)	-3.33 ± 22.500
School Functioning: Cycle4 Week12 (n=9)	0.00 ± 15.000
School Functioning: Cycle4 Week24 (n=7)	13.57 ± 8.018
School Functioning: Cycle5 Week12 (n=5)	15.00 ± 11.180
School Functioning: Cycle5 Week24 (n=4)	18.75 ± 8.539
School Functioning: Cycle6 Week12 (n=4)	13.75 ± 4.787
School Functioning: Cycle6 Week24 (n=1)	20.00 ± 99999

No statistical analyses for this end point

Other pre-specified: Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at End of Study (EOS) During the End of Non-Teduglutide Treatment (NTT) Periods in Prospective Study Period

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End point title

Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at End of Study (EOS) During the End of Non-Teduglutide Treatment (NTT) Periods in Prospective Study Period

End point description

PedsQL GCS was used for quality of life assessment. It encompasses 4 dimensions of functioning (physical, emotional, social, school). Age groups are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Teens (13-18 years). Depending on the subject’s age, the questionnaire may be completed by either the participant or the parent/caregiver as appropriate. For the Toddler group, the PedsQL GCS consists of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consists of 23 items, with a 3-point Likert scale (0, 2, 4) for the young child, and a 5-point Likert scale for the child and teens groups. 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. Safety population analysis.

End point type

Other pre-specified

End point timeframe

Baseline: From end of retrospective study period, EOS (up to Week 28)

End point values	Prospective TED/NTT Group	Prospective TED/TED Group
Number of subjects analysed	0 ^[25]	0 ^[26]
Units: Scale on a score
arithmetic mean (standard deviation)
Physical Functioning: EOS	±	±
Emotional Functioning: EOS	±	±
Social Functioning: EOS	±	±
School Functioning: EOS	±	±

Notes
[25] - No subjects were analysed at EOS.
[26] - No subjects were analysed at EOS.

No statistical analyses for this end point

Other pre-specified: Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Family Impact Module Total Score at Week 12 and 24 of Each Treatment Cycle During the End of Each Teduglutide Treatment Period in Prospective Study Period

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End point title

Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Family Impact Module Total Score at Week 12 and 24 of Each Treatment Cycle During the End of Each Teduglutide Treatment Period in Prospective Study Period

End point 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 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. Safety population analysis. Here, n=number of subjects analysed refer to subjects evaluable for this category. Here, '99999' indicates standard deviation was not estimated as only single subject was analysed. Since baseline scores were unavailable for TED/NTT group, data was not analysed for this arm.

End point type

Other pre-specified

End point timeframe

Baseline: From end of retrospective study period, Week 12 and 24 of each treatment cycle

End point values	Prospective TED/TED Group
Number of subjects analysed	19
Units: Score on a Scale
arithmetic mean (standard deviation)
Total Score: Cycle1 Week12 (n=18)	1.39 ± 15.742
Total Score: Cycle1 Week24 (n=19)	1.56 ± 13.372
Total Score: Cycle2 Week12 (n=15)	0.10 ± 13.622
Total Score: Cycle2 Week24 (n=16)	1.90 ± 11.664
Total Score: Cycle3 Week12 (n=13)	2.72 ± 15.051
Total Score: Cycle3 Week24 (n=11)	3.90 ± 16.018
Total Score: Cycle4 Week12 (n=10)	2.14 ± 20.762
Total Score: Cycle4 Week24 (n=9)	4.66 ± 23.546
Total Score: Cycle5 Week12 (n=8)	0.11 ± 14.105
Total Score: Cycle5 Week24 (n=6)	2.23 ± 16.099
Total Score: Cycle6 Week12 (n=4)	5.13 ± 18.084
Total Score: Cycle6 Week24 (n=1)	-17.86 ± 99999

No statistical analyses for this end point

Other pre-specified: Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Family Impact Module Total Score at End of Study (EOS) During the End of Non-Teduglutide Treatment (NTT) Periods of Prospective Study Period

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End point title

Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Family Impact Module Total Score at End of Study (EOS) During the End of Non-Teduglutide Treatment (NTT) Periods of Prospective Study Period

End point description

End point type

Other pre-specified

End point timeframe

Baseline: From end of retrospective study period, EOS (up to Week 28)

End point values	Prospective TED/NTT Group	Prospective TED/TED Group
Number of subjects analysed	0 ^[27]	0 ^[28]
Units: Score on a scale
arithmetic mean (standard deviation)
Total score: EOS	±	±

Notes
[27] - No subjects were analysed at EOS.
[28] - No subjects were analysed at EOS.

No statistical analyses for this end point

Other pre-specified: Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

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End point title

Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

End point description

PedsQL GI 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. Subscale 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. Safety population analysis. Here, n=number of subjects analysed refer to subjects evaluable for this category. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed. Since baseline scores were unavailable for TED/NTT group, data was not analysed for this arm.

End point type

Other pre-specified

End point timeframe

Baseline: From end of retrospective study period, Week 12 and 24 of each treatment cycle

End point values	Prospective TED/TED Group
Number of subjects analysed	19
Units: Score on a scale
arithmetic mean (standard deviation)
Food and Drink Limits: Cycle1Week12 (n=18)	-2.08 ± 30.460
Food and Drink Limits: Cycle1Week24 (n=19)	-7.06 ± 27.524
Food and Drink Limits: Cycle2Week12 (n=15)	-0.83 ± 29.723
Food and Drink Limits: Cycle2Week24 (n=17)	9.31 ± 26.292
Food and Drink Limits: Cycle3Week12 (n=14)	1.19 ± 35.784
Food and Drink Limits: Cycle3Week24 (n=11)	-0.08 ± 29.511
Food and Drink Limits: Cycle4Week12 (n=9)	-4.63 ± 33.750
Food and Drink Limits: Cycle4Week24 (n=8)	1.04 ± 35.895
Food and Drink Limits: Cycle5Week12 (n=7)	1.19 ± 21.343
Food and Drink Limits: Cycle5Week24 (n=6)	-17.36 ± 44.986
Food and Drink Limits: Cycle6Week12 (n=3)	-1.39 ± 30.142
Food and Drink Limits: Cycle6Week24 (n=1)	-45.83 ± 99999
Diarrhea: Cycle1Week12 (n=18)	7.79 ± 23.137
Diarrhea: Cycle1Week24 (n=18)	9.33 ± 23.279
Diarrhea: Cycle2Week12 (n=15)	5.48 ± 15.144
Diarrhea: Cycle2Week24 (n=17)	6.72 ± 19.880
Diarrhea: Cycle3Week12 (n=14)	13.27 ± 22.124
Diarrhea: Cycle3Week24 (n=11)	5.19 ± 21.569
Diarrhea: Cycle4Week12 (n=9)	9.13 ± 18.653
Diarrhea: Cycle4Week24 (n=8)	12.95 ± 26.448
Diarrhea: Cycle5Week12 (n=7)	10.71 ± 23.237
Diarrhea: Cycle5Week24 (n=6)	8.33 ± 30.612
Diarrhea: Cycle6Week12 (n=3)	5.95 ± 22.961
Diarrhea: Cycle6Week24 (n=1)	-7.14 ± 99999

No statistical analyses for this end point

Other pre-specified: Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at End of Study (EOS) During the End of Non-Teduglutide Treatment (NTT) Periods of Prospective Study Period

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End point title

Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at End of Study (EOS) During the End of Non-Teduglutide Treatment (NTT) Periods of Prospective Study Period

End point description

End point type

Other pre-specified

End point timeframe

Baseline: From end of retrospective study period, EOS (up to Week 28)

End point values	Prospective TED/NTT Group	Prospective TED/TED Group
Number of subjects analysed	0 ^[29]	0 ^[30]
Units: Score on a scale
arithmetic mean (standard deviation)
Food and Drink Limits :EOS	±	±
Diarrhea: EOS	±	±

Notes
[29] - No subjects were analysed at EOS.
[30] - No subjects were analysed at EOS.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From start of screening up to follow up (Week 28)

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

19.1

Reporting group title

Retrospective TED/NTT Group

Reporting group description

Subjects who received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (2013-004588-30) and didn't received teduglutide in retrospective period in the current study SHP633-303.

Reporting group title

Retrospective TED/TED Group

Reporting group description

Subjects who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (2013-004588-30) and also received teduglutide in retrospective period in the current study SHP633-303.

Reporting group title

Prospective TED/NTT Group

Reporting group description

Subjects who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (2013-004588-30) and didn't received teduglutide in prospective period in the current study SHP633-303 up to 24 weeks.

Reporting group title

Prospective TED/TED Group

Reporting group description

Subjects who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (2013-004588-30) and also received teduglutide in prospective period in the current study SHP633-303 up to 24 weeks.

Serious adverse events	Retrospective TED/NTT Group	Retrospective TED/TED Group	Prospective TED/NTT Group	Prospective TED/TED Group
Total subjects affected by serious adverse events
subjects affected / exposed	23 / 24 (95.83%)	4 / 5 (80.00%)	3 / 5 (60.00%)	17 / 19 (89.47%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0
Vascular disorders
Superior vena cava occlusion
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Superior vena cava syndrome
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Catheter management
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Central venous catheterisation
subjects affected / exposed	2 / 24 (8.33%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Complication associated with device
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Face oedema
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hyperpyrexia
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	14 / 24 (58.33%)	3 / 5 (60.00%)	0 / 5 (0.00%)	7 / 19 (36.84%)
occurrences causally related to treatment / all	0 / 31	0 / 6	0 / 0	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Systemic inflammatory response syndrome
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tachypnoea
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Product issues
Device breakage
subjects affected / exposed	6 / 24 (25.00%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 8	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Device dislocation
subjects affected / exposed	0 / 24 (0.00%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Device failure
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Device malfunction
subjects affected / exposed	5 / 24 (20.83%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Device occlusion
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Influenza a virus test positive
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcus test positive
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Weight decreased
subjects affected / exposed	0 / 24 (0.00%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Anastomotic ulcer
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital, familial and genetic disorders
Congenital megacolon
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Tachycardia
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Haemorrhagic anaemia
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Microcytic anaemia
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal adhesions
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Duodenal ulcer
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Enteritis
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Functional gastrointestinal disorder
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal hypomotility
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ileus
subjects affected / exposed	1 / 24 (4.17%)	1 / 5 (20.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ileus paralytic
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	2 / 24 (8.33%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Short-bowel syndrome
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Small intestinal stenosis
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	2 / 24 (8.33%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Hepatic failure
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Jaundice
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Skin irritation
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Adenovirus infection
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	2 / 24 (8.33%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bacterial infection
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchiolitis
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cystitis
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Device related infection
subjects affected / exposed	17 / 24 (70.83%)	2 / 5 (40.00%)	1 / 5 (20.00%)	9 / 19 (47.37%)
occurrences causally related to treatment / all	0 / 33	0 / 6	0 / 1	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Device related sepsis
subjects affected / exposed	0 / 24 (0.00%)	1 / 5 (20.00%)	1 / 5 (20.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Enterococcal infection
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Fungal infection
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	2 / 19 (10.53%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Influenza
subjects affected / exposed	5 / 24 (20.83%)	0 / 5 (0.00%)	0 / 5 (0.00%)	4 / 19 (21.05%)
occurrences causally related to treatment / all	0 / 5	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metapneumovirus infection
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Micrococcus infection
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Parainfluenzae virus infection
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory syncytial virus bronchiolitis
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory syncytial virus infection
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Rhinovirus infection
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Rotavirus infection
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcal bacteraemia
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	2 / 24 (8.33%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	2 / 24 (8.33%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Viral infection
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Viral pharyngitis
subjects affected / exposed	0 / 24 (0.00%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Viral upper respiratory tract infection
subjects affected / exposed	0 / 24 (0.00%)	1 / 5 (20.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	2 / 24 (8.33%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Electrolyte imbalance
subjects affected / exposed	2 / 24 (8.33%)	1 / 5 (20.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Feeding intolerance
subjects affected / exposed	0 / 24 (0.00%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypoalbuminaemia
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Lactic acidosis
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolic acidosis
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	1 / 5 (20.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Weight gain poor
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Retrospective TED/NTT Group	Retrospective TED/TED Group	Prospective TED/NTT Group	Prospective TED/TED Group
Total subjects affected by non serious adverse events
subjects affected / exposed	1 / 24 (4.17%)	1 / 5 (20.00%)	4 / 5 (80.00%)	18 / 19 (94.74%)
Vascular disorders
Flushing
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
General disorders and administration site conditions
Administration site extravasation
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Catheter site inflammation
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	1 / 19 (5.26%)
occurrences all number	0	0	1	1
Fatigue
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	3
Generalised oedema
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Ill-defined disorder
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Injection site induration
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Injection site pain
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	2
Injection site reaction
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Injection site swelling
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Medical device site irritation
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Pyrexia
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	2
Secretion discharge
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Immune system disorders
Food allergy
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	4
Hypersensitivity
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Seasonal allergy
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	2
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	6 / 19 (31.58%)
occurrences all number	0	0	0	8
Dyspnoea
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	2 / 19 (10.53%)
occurrences all number	0	0	1	2
Epistaxis
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	10
Nasal congestion
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Oropharyngeal pain
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	3 / 19 (15.79%)
occurrences all number	0	0	0	3
Pleuritic pain
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Rhinorrhoea
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Psychiatric disorders
Aggression
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Attention deficit/hyperactivity disorder
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Depression
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences all number	0	0	1	0
Sleep disorder
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Product issues
Device dislocation
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Device leakage
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Device occlusion
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	3 / 19 (15.79%)
occurrences all number	0	0	0	4
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Bacterial test positive
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	3 / 19 (15.79%)
occurrences all number	0	0	0	3
Blood albumin decreased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Blood creatine increased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences all number	0	0	1	0
Blood creatinine increased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences all number	0	0	2	0
Blood iron decreased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Blood sodium decreased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Blood urine present
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Body temperature increased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
C-reactive protein increased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	5 / 19 (26.32%)
occurrences all number	0	0	0	6
Gamma-glutamyltransferase increased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Gastrointestinal stoma output increased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Haematocrit decreased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Haemoglobin decreased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Heart rate increased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	2
Hepatic enzyme increased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Lipase increased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Lymph node palpable
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Occult blood positive
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Platelet count increased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences all number	0	0	1	0
Serum ferritin decreased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Streptococcus test positive
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Vitamin a decreased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Weight decreased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
White blood cells urine positive
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	2
pH urine increased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	2
Infusion related reaction
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	3
Medication error
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Procedural pain
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Skin abrasion
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Nervous system disorders
Dizziness
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	3 / 19 (15.79%)
occurrences all number	0	0	0	4
Dysarthria
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Headache
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	5 / 19 (26.32%)
occurrences all number	0	0	1	16
Lethargy
subjects affected / exposed	1 / 24 (4.17%)	0 / 5 (0.00%)	0 / 5 (0.00%)	3 / 19 (15.79%)
occurrences all number	1	0	0	6
Migraine
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Seizure
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Syncope
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	3 / 19 (15.79%)
occurrences all number	0	0	2	7
Lymphadenopathy
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Ear and labyrinth disorders
Ear pain
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Middle ear effusion
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Eye disorders
Visual impairment
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Abdominal distension
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	3 / 19 (15.79%)
occurrences all number	0	0	0	3
Abdominal pain
subjects affected / exposed	0 / 24 (0.00%)	1 / 5 (20.00%)	2 / 5 (40.00%)	7 / 19 (36.84%)
occurrences all number	0	1	4	22
Abdominal pain upper
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	7
Constipation
subjects affected / exposed	0 / 24 (0.00%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	1	0	0
Diarrhoea
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	5 / 19 (26.32%)
occurrences all number	0	0	0	10
Dyspepsia
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	3
Faecal volume increased
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	3
Faeces discoloured
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Flatulence
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Frequent bowel movements
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	3
Gastritis
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	2
Gastroenteritis eosinophilic
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Haematochezia
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	3
Lip swelling
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	2
Nausea
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	3 / 19 (15.79%)
occurrences all number	0	0	0	7
Oral mucosal erythema
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Perianal erythema
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Post-tussive vomiting
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences all number	0	0	1	0
Proctalgia
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	3
Proctitis
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Rectal discharge
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	8
Toothache
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Vomiting
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	2 / 5 (40.00%)	10 / 19 (52.63%)
occurrences all number	0	0	3	55
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences all number	0	0	1	0
Cold sweat
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Dry skin
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Eczema
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	2
Erythema
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences all number	0	0	1	0
Nodular rash
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Pruritus
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Rash
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	4 / 19 (21.05%)
occurrences all number	0	0	1	4
Rash erythematous
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences all number	0	0	1	0
Rash pruritic
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Swelling face
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	2
Renal and urinary disorders
Haematuria
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Endocrine disorders
Adrenal insufficiency
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	1 / 19 (5.26%)
occurrences all number	0	0	1	1
Back pain
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences all number	0	0	1	0
Musculoskeletal pain
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Pain in extremity
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	2
Infections and infestations
Bronchiolitis
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences all number	0	0	1	0
Cellulitis
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences all number	0	0	1	0
Croup infectious
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	1 / 19 (5.26%)
occurrences all number	0	0	1	1
Device related infection
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Ear infection
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	2
Escherichia urinary tract infection
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences all number	0	0	1	0
Furuncle
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Gastroenteritis
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	3 / 19 (15.79%)
occurrences all number	0	0	0	5
Gastroenteritis viral
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	3 / 19 (15.79%)
occurrences all number	0	0	0	3
Impetigo
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Influenza
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	3
Lyme disease
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Nasopharyngitis
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	3 / 19 (15.79%)
occurrences all number	0	0	0	7
Otitis media
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	4
Pharyngitis streptococcal
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	3
Respiratory tract infection
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	4
Rhinovirus infection
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences all number	0	0	1	0
Upper respiratory tract infection
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	3 / 5 (60.00%)	7 / 19 (36.84%)
occurrences all number	0	0	5	18
Urinary tract infection
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	3 / 19 (15.79%)
occurrences all number	0	0	0	3
Viral infection
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	3 / 19 (15.79%)
occurrences all number	0	0	1	5
Viral upper respiratory tract infection
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	2 / 5 (40.00%)	0 / 19 (0.00%)
occurrences all number	0	0	2	0
Metabolism and nutrition disorders
Acidosis
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Decreased appetite
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	2
Dehydration
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Hyperkalaemia
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Hypocalcaemia
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences all number	0	0	1	0
Hypochloraemia
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1
Hypoglycaemia
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences all number	0	0	1	0
Hypokalaemia
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences all number	0	0	1	0
Metabolic acidosis
subjects affected / exposed	0 / 24 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 19 (0.00%)
occurrences all number	0	0	1	0

More information

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Were there any global substantial amendments to the protocol? Yes

22 Nov 2016

Protocol Amendment 1: - Reporting of AEs during the retrospective period was clarified and corrected for consistency across safety sections of the protocol. Only non-serious AEs related (instead of possibly related) to teduglutide needed to be reported. No changes to the protocol were made for the reporting of all AESIs or any SAEs, regardless of relationship to teduglutide, that occurred during the retrospective period. - Clarification that the interim analysis was to be conducted on all retrospective data, and other interim analyses might also be conducted if needed.

17 Mar 2017

Protocol Amendment 2: - Inclusion criterion 1 to ensure that subjects whose prior exposure to teduglutide in Study the core study may not have been enough to assess efficacy were eligible to receive treatment in Study SHP633-303. - To specify that a severe TEAE that might lead to dose interruption was also to be graded according to the NCI CTCAE severity grading criteria, in addition to the standard severity categorization (US Department of Health and Human Services et al., 2010). These events were no longer limited to only the events described in the former table entitled “CTCAE Criteria for Adverse Events that May Lead to Dose Interruption (Prospective Period of Observation Only).” Therefore, this table (Table 8-1 of the protocol) was deleted from the protocol.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Retrospective and Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Subjects with Short Bowel Syndrome Who Completed TED-C13-003

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Subjects With Adverse Events (AEs), Related AEs, Serious Adverse Events (SAEs) and Related SAEs of Retrospective Observation Period

Primary: Number of Subjects With Adverse Events (AEs), Related AEs, Serious Adverse Events (SAEs) and Related SAEs of Retrospective Observation Period

Primary: Change From Baseline in Height for Age Z-score at Week 168 of Retrospective Observation Period

Primary: Change From Baseline in Height for Age Z-score at Week 168 of Retrospective Observation Period

Primary: Change From Baseline in Body Weight for age Z-score at Week 168 of Retrospective Observation Period

Primary: Change From Baseline in Body Weight for age Z-score at Week 168 of Retrospective Observation Period

Primary: Change From Baseline in Head Circumference for Age Z-score at Week 12 of Retrospective Observation Period

Primary: Change From Baseline in Head Circumference for Age Z-score at Week 12 of Retrospective Observation Period

Primary: Change From Baseline in Body Mass Index (BMI) for Age Z-score at Week 168 of Retrospective Observation Period

Primary: Change From Baseline in Body Mass Index (BMI) for Age Z-score at Week 168 of Retrospective Observation Period

Primary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESI) of Prospective Study Period

Primary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESI) of Prospective Study Period

Primary: Change From Baseline in Height for Age Z-score at Cycle 6 Week 12 During the End of Each Teduglutide Treatment Period of Prospective Study Period

Primary: Change From Baseline in Height for Age Z-score at Cycle 6 Week 12 During the End of Each Teduglutide Treatment Period of Prospective Study Period

Primary: Change From Baseline in Body Weight for Age Z-score at Cycle 6 Week 24 During the End of Each Teduglutide Treatment Period of Prospective Study Period

Primary: Change From Baseline in Body Weight for Age Z-score at Cycle 6 Week 24 During the End of Each Teduglutide Treatment Period of Prospective Study Period

Primary: Change From Baseline in Body Mass Index (BMI) for Age Z-score at Cycle 6 Week 12 During the End of Each Teduglutide Treatment Period of Prospective Study Period

Primary: Change From Baseline in Body Mass Index (BMI) for Age Z-score at Cycle 6 Week 12 During the End of Each Teduglutide Treatment Period of Prospective Study Period

Primary: Average Total 48-Hour Urine Output at Cycle 6 Week 12 During the End of Each Teduglutide Treatment Period of Prospective Study Period

Primary: Average Total 48-Hour Urine Output at Cycle 6 Week 12 During the End of Each Teduglutide Treatment Period of Prospective Study Period

Primary: Average Total 48-Hour Urine Output at End of Study (EOS) During the End of Non-Teduglutide Treatment (NTT) Period of Prospective Study Period

Primary: Average Total 48-Hour Urine Output at End of Study (EOS) During the End of Non-Teduglutide Treatment (NTT) Period of Prospective Study Period

Primary: Average Number of Stools per Day at Cycle 6 Week 24 During the End of Each Teduglutide Treatment Period of Prospective Study Period

Primary: Average Number of Stools per Day at Cycle 6 Week 24 During the End of Each Teduglutide Treatment Period of Prospective Study Period

Primary: Average Number of Stools per Day at End of Study (EOS) During the End of Non-Teduglutide Treatment (NTT) Period of Prospective Study Period

Primary: Average Number of Stools per Day at End of Study (EOS) During the End of Non-Teduglutide Treatment (NTT) Period of Prospective Study Period

Primary: Number of Subjects With Positive Specific Antibodies at End of Study (EOS) During the End of Each Teduglutide Treatment Period of Prospective Study Period

Primary: Number of Subjects With Positive Specific Antibodies at End of Study (EOS) During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Number of Participants Achieved At least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

Secondary: Number of Participants Achieved At least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

Secondary: Change From Baseline in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

Secondary: Change From Baseline in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

Secondary: Percent Change From Baseline in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

Secondary: Percent Change From Baseline in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

Secondary: Change From Baseline in Parenteral Support (PS) Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

Secondary: Change From Baseline in Parenteral Support (PS) Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

Secondary: Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

Secondary: Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

Secondary: Change From Baseline in Number of Hours per Day of Parenteral Support (PS) Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

Secondary: Change From Baseline in Number of Hours per Day of Parenteral Support (PS) Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

Secondary: Percent Change From Baseline in Number of Hours per Day of Parenteral Support (PS) Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

Secondary: Percent Change From Baseline in Number of Hours per Day of Parenteral Support (PS) Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

Secondary: Change From Baseline in Number of Days per Week of Parenteral Support (PS) Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

Secondary: Change From Baseline in Number of Days per Week of Parenteral Support (PS) Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

Secondary: Percent Change From Baseline in Number of Days per Week of Parenteral Support (PS) Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

Secondary: Percent Change From Baseline in Number of Days per Week of Parenteral Support (PS) Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period

Secondary: Number of Participants Who Achieved At least 20, 50 and 75 Percent (%) Reduction in Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Number of Participants Who Achieved At least 20, 50 and 75 Percent (%) Reduction in Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Percent Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Percent Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Number of Subjects Who Achieved 100 Percent (%) Reduction in Complete Weaning of Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Number of Subjects Who Achieved 100 Percent (%) Reduction in Complete Weaning of Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Change From Baseline in Number of Hours per Day of Parenteral Support (PS) Usage at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Change From Baseline in Number of Hours per Day of Parenteral Support (PS) Usage at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Percent Change From Baseline in Number of Hours per Day of Parenteral Support (PS) Usage at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Percent Change From Baseline in Number of Hours per Day of Parenteral Support (PS) Usage at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Change From Baseline in Number of Days per Week of Parenteral Support (PS) Usage at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Change From Baseline in Number of Days per Week of Parenteral Support (PS) Usage at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Percent Change From Baseline in Number of Days per Week of Parenteral Support (PS) Usage at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Secondary: Percent Change From Baseline in Number of Days per Week of Parenteral Support (PS) Usage at End of Treatment (EOT) of Each Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Other pre-specified: Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Other pre-specified: Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the End of Each Teduglutide Treatment Period of Prospective Study Period

Other pre-specified: Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at End of Study (EOS) During the End of Non-Teduglutide Treatment (NTT) Periods in Prospective Study Period

Other pre-specified: Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at End of Study (EOS) During the End of Non-Teduglutide Treatment (NTT) Periods in Prospective Study Period

Clinical Trial Results:
A Retrospective and Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Subjects with Short Bowel Syndrome Who Completed TED-C13-003