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    Clinical Trial Results:
    A Prospective, Open-Label, Long-Term Safety and Efficacy Study of Teduglutide in Pediatric Patients With Short Bowel Syndrome Who Completed TED-C14-006 or SHP633-301

    Summary
    EudraCT number
    2016-000849-30
    Trial protocol
    BE   FI   IT   GB   FR  
    Global end of trial date
    05 Nov 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    16 May 2021
    First version publication date
    16 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SHP633-304
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02954458
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Shire
    Sponsor organisation address
    300 ShireWay, Lexington, United States, MA 02421
    Public contact
    Study Director, Shire, +1 866 842 5335, ClinicalTransparency@takeda.com
    Scientific contact
    Study Director, Shire, +1 866 842 5335, ClinicalTransparency@takeda.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Nov 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the long-term safety and tolerability of teduglutide treatment in pediatric subjects with short bowel syndrome (SBS) who completed their core study.
    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 (ICH) Good Clinical Practice Guideline E6 (1996), European Union (EU) 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 Jan 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    Finland: 4
    Country: Number of subjects enrolled
    United Kingdom: 12
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    United States: 39
    Worldwide total number of subjects
    61
    EEA total number of subjects
    6
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    6
    Children (2-11 years)
    51
    Adolescents (12-17 years)
    3
    Adults (18-64 years)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 23 sites across the United States, Belgium, Canada, United Kingdom, Finland, and Italy between 09 January 2017 (first subject first visit) and 05 Nov 2020 (last subject last visit).

    Pre-assignment
    Screening details
    Total of 61 subjects (children and infant) were enrolled in 4 groups: Non-teduglutide/Non-teduglutide(NTT/NTT), Non-teduglutide/Teduglutide(NTT/TED), Teduglutide /Non-teduglutide(TED/NTT) and Teduglutide/Teduglutide(TED/TED). Subjects who completed core study TED-C14-006 [2015-002252-27] or SHP633-301 [2017-003606-40] were eligible for this study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)
    Arm description
    Subjects who participated in standard of care arm in the core study TED-C14-006 [2015-002252-27] or SHP633-301 [2017-003606-40] were enrolled into this extension study but did not receive any teduglutide treatment in no-teduglutide period up to 39 months (Each visit =12 weeks of cycle up to 14 visits) in the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Teduglutide
    Investigational medicinal product code
    SHP633
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects who participated in standard of care arm in the core study and did not receive any teduglutide treatment in the this extension study.

    Arm title
    Non-teduglutide/Teduglutide Treatment (NTT/TED)
    Arm description
    Subjects who participated in standard of care arm in the core study TED-C14-006 [2015-002252-27] or SHP633-301 [2017-003606-40] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 36 months (Up to 6 Cycles [each Cycle 1 to 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks]).
    Arm type
    Experimental

    Investigational medicinal product name
    Teduglutide
    Investigational medicinal product code
    SHP633
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects who participated in standard of care arm in the core study and received 0.05 mg/kg teduglutide once daily in this extension study.

    Arm title
    Teduglutide /Non-teduglutide Treatment (TED/NTT)
    Arm description
    Subjects who received teduglutide in the core study TED-C14-006 [2015-002252-27] or SHP633-301 [2017-003606-40] were enrolled into this extension study but did not receive any teduglutide treatment in no-teduglutide period up to 39 months (Each visit =12 weeks of cycle up to 14 visits) in the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Teduglutide
    Investigational medicinal product code
    SHP633
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 0.05 mg/kg teduglutide in the core study but not in the this extension study;

    Arm title
    Teduglutide/Teduglutide Treatment (TED/TED)
    Arm description
    Subjects who received teduglutide in the core study TED-C14-006 [2015-002252-27] or SHP633-301 [2017-003606-40] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 36 months (Up to 6 Cycles [each Cycle 1 to 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks]).
    Arm type
    Experimental

    Investigational medicinal product name
    Teduglutide
    Investigational medicinal product code
    SHP633
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 0.05 mg/kg teduglutide once daily in the core study and in this extension study.

    Number of subjects in period 1
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide /Non-teduglutide Treatment (TED/NTT) Teduglutide/Teduglutide Treatment (TED/TED)
    Started
    7
    3
    1
    50
    Completed
    6
    3
    0
    38
    Not completed
    1
    0
    1
    12
         Physician decision
    -
    -
    1
    1
         Adverse event, serious fatal
    -
    -
    -
    1
         Adverse event, non-fatal
    -
    -
    -
    1
         Unspecified
    -
    -
    -
    7
         Consent withdrawn by subject
    -
    -
    -
    1
         Lost to follow-up
    1
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)
    Reporting group description
    Subjects who participated in standard of care arm in the core study TED-C14-006 [2015-002252-27] or SHP633-301 [2017-003606-40] were enrolled into this extension study but did not receive any teduglutide treatment in no-teduglutide period up to 39 months (Each visit =12 weeks of cycle up to 14 visits) in the study.

    Reporting group title
    Non-teduglutide/Teduglutide Treatment (NTT/TED)
    Reporting group description
    Subjects who participated in standard of care arm in the core study TED-C14-006 [2015-002252-27] or SHP633-301 [2017-003606-40] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 36 months (Up to 6 Cycles [each Cycle 1 to 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks]).

    Reporting group title
    Teduglutide /Non-teduglutide Treatment (TED/NTT)
    Reporting group description
    Subjects who received teduglutide in the core study TED-C14-006 [2015-002252-27] or SHP633-301 [2017-003606-40] were enrolled into this extension study but did not receive any teduglutide treatment in no-teduglutide period up to 39 months (Each visit =12 weeks of cycle up to 14 visits) in the study.

    Reporting group title
    Teduglutide/Teduglutide Treatment (TED/TED)
    Reporting group description
    Subjects who received teduglutide in the core study TED-C14-006 [2015-002252-27] or SHP633-301 [2017-003606-40] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 36 months (Up to 6 Cycles [each Cycle 1 to 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks]).

    Reporting group values
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide /Non-teduglutide Treatment (TED/NTT) Teduglutide/Teduglutide Treatment (TED/TED) Total
    Number of subjects
    7 3 1 50 61
    Age categorical
    Units:
    Age Continuous
    Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed for the specified arm.
    Units: years
        arithmetic mean (standard deviation)
    5.8 ± 5.43 1.5 ± 0.80 6.0 ± 99999 5.7 ± 3.69 -
    Sex: Female, Male
    Units: Subjects
        Female
    3 1 0 16 20
        Male
    4 2 1 34 41
    Race, Customized
    Units: Subjects
        White
    3 0 1 38 42
        Black or African American
    1 0 0 6 7
        Asian
    1 1 0 1 3
        American Indian or Alaska Native
    0 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    0 0 0 0 0
        Other
    1 1 0 1 3
        Not allowed based on local regulations
    1 1 0 4 6
    Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    3 1 0 10 14
        Not Hispanic or Latino
    3 1 1 35 40
        Not allowed based on local regulations
    1 1 0 5 7

    End points

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    End points reporting groups
    Reporting group title
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)
    Reporting group description
    Subjects who participated in standard of care arm in the core study TED-C14-006 [2015-002252-27] or SHP633-301 [2017-003606-40] were enrolled into this extension study but did not receive any teduglutide treatment in no-teduglutide period up to 39 months (Each visit =12 weeks of cycle up to 14 visits) in the study.

    Reporting group title
    Non-teduglutide/Teduglutide Treatment (NTT/TED)
    Reporting group description
    Subjects who participated in standard of care arm in the core study TED-C14-006 [2015-002252-27] or SHP633-301 [2017-003606-40] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 36 months (Up to 6 Cycles [each Cycle 1 to 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks]).

    Reporting group title
    Teduglutide /Non-teduglutide Treatment (TED/NTT)
    Reporting group description
    Subjects who received teduglutide in the core study TED-C14-006 [2015-002252-27] or SHP633-301 [2017-003606-40] were enrolled into this extension study but did not receive any teduglutide treatment in no-teduglutide period up to 39 months (Each visit =12 weeks of cycle up to 14 visits) in the study.

    Reporting group title
    Teduglutide/Teduglutide Treatment (TED/TED)
    Reporting group description
    Subjects who received teduglutide in the core study TED-C14-006 [2015-002252-27] or SHP633-301 [2017-003606-40] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 36 months (Up to 6 Cycles [each Cycle 1 to 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks]).

    Primary: Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

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    End point title
    Number of Subjects With Treatment-emergent Adverse Events (TEAEs) [1]
    End point description
    An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs that started or worsened on or after the date of first dose of teduglutide for subjects in the TED/TED, TED/NTT, and NTT/TED treatment groups, or after the core study baseline visit for subjects in the NTT/NTT group. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria.
    End point type
    Primary
    End point timeframe
    From start of study drug administration up to follow-up (up to Month 46)
    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 comparision analyses were performed for this endpoint.
    End point values
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide /Non-teduglutide Treatment (TED/NTT) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    7
    3
    1
    50
    Units: Subjects
    6
    3
    1
    50
    No statistical analyses for this end point

    Primary: Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment Period [2] [3]
    End point description
    Average total urine output was recorded over a 48-hour period of parental support (PS) stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily urine output milliliter per kilogram per day (mL/kg/day) was calculated as: Total urine output over 48 hours / 2) / body weight (kilogram [kg]) where total urine output was calculated as the sum of the urine output in milliliter (mL) and the urine-only diaper weights in gram (g) (1g = 1mL) for the subject collected on the output diary form of electronic case report from (eCRF). The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analyzed refer to the subjects evaluable for this endpoint. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Primary
    End point timeframe
    Baseline, EOT of last cycle (Up to Month 36) (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    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 comparision analyses were performed for this endpoint.
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    2
    32
    Units: mL/kg/day
        arithmetic mean (standard deviation)
    0.26 ± 1.692
    2.51 ± 22.607
    No statistical analyses for this end point

    Primary: Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide (NT) Period

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    End point title
    Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide (NT) Period [4]
    End point description
    Average total urine output was recorded over a 48 hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. Average daily urine output mL/kg/day was calculated as: (Total urine output over 48 hours / 2) / body weight (kg) where total urine output was calculated as the sum of the urine output in mL and the urine-only diaper weights in gram (1g = 1mL) for the subject collected on the output diary form of electronic case report from (eCRF). The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analyzed refer to the subjects evaluable for this endpoint. 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, Last visit in NT (up to Month 39) (Each visit= 12 weeks)
    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 comparision analyses were performed for this endpoint.
    End point values
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide /Non-teduglutide Treatment (TED/NTT) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    4
    0 [5]
    1
    11
    Units: mL/kg/day
        arithmetic mean (standard deviation)
    -0.89 ± 7.431
    ±
    15.01 ± 99999
    -6.87 ± 26.299
    Notes
    [5] - Data was not collected and analysed at this time point, for this respective arm.
    No statistical analyses for this end point

    Primary: Change From Baseline in Average Number of Stools per Day at EOT of Last Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline in Average Number of Stools per Day at EOT of Last Cycle During Teduglutide Treatment Period [6] [7]
    End point description
    Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2).The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analyzed refer to the subjects evaluable for this endpoint. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Primary
    End point timeframe
    Baseline, EOT of last cycle (Up to Month 36) (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    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 comparision analyses were performed for this endpoint.
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    0 [8]
    32
    Units: Stools per day
        arithmetic mean (standard deviation)
    ±
    -0.47 ± 2.272
    Notes
    [8] - Data was not collected and analysed at this time point, for this respective arm.
    No statistical analyses for this end point

    Primary: Change From Baseline in Average Number of Stools per Day at Last Visit During Non-Teduglutide Period

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    End point title
    Change From Baseline in Average Number of Stools per Day at Last Visit During Non-Teduglutide Period [9]
    End point description
    Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2). The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analyzed refer to the subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Last visit in NT (up to Month 39) (Each visit= 12 weeks)
    Notes
    [9] - 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 comparision analyses were performed for this endpoint.
    End point values
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide /Non-teduglutide Treatment (TED/NTT) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    4
    0 [10]
    0 [11]
    14
    Units: Stools per day
        arithmetic mean (standard deviation)
    -0.50 ± 0.913
    ±
    ±
    0.38 ± 1.780
    Notes
    [10] - Data was not collected and analysed at this time point, for this respective arm.
    [11] - Data was not collected and analysed at this time point, for this respective arm.
    No statistical analyses for this end point

    Primary: Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment Period [12] [13]
    End point description
    Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average total daily stool/mixed stool diaper weight (gram per kilogram per day [g/kg/day]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day). The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analyzed refer to the subjects evaluable for this endpoint. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed for the specified arm. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Primary
    End point timeframe
    Baseline, EOT of last cycle (Up to Month 36) (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    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 comparision analyses were performed for this endpoint.
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    1
    7
    Units: g/day
        arithmetic mean (standard deviation)
    0.00 ± 99999
    -11.35 ± 25.667
    No statistical analyses for this end point

    Primary: Change from Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at Last Visit During Non-Teduglutide Period

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    End point title
    Change from Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at Last Visit During Non-Teduglutide Period [14]
    End point description
    Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average total daily stool/mixed stool diaper weight (g/kg/day). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day). The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analyzed refer to the subjects evaluable for this endpoint. 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, Last visit in NT (up to Month 39) (Each visit= 12 weeks)
    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 comparision analyses were performed for this endpoint.
    End point values
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide /Non-teduglutide Treatment (TED/NTT) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    1
    0 [15]
    0 [16]
    4
    Units: g/day
        arithmetic mean (standard deviation)
    0.31 ± 99999
    ±
    ±
    -4.98 ± 20.892
    Notes
    [15] - Data was not collected and analysed at this time point, for this respective arm.
    [16] - Data was not collected and analysed at this time point, for this respective arm.
    No statistical analyses for this end point

    Primary: Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment Period [17] [18]
    End point description
    Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average ostomy output per day (mL/kg/day). The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analyzed refer to the subjects evaluable for this endpoint. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Primary
    End point timeframe
    Baseline, EOT of last cycle (Up to Month 36) (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    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 comparision analyses were performed for this endpoint.
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    2
    5
    Units: mL/kg/day
        arithmetic mean (standard deviation)
    -12.52 ± 11.675
    12.16 ± 35.079
    No statistical analyses for this end point

    Primary: Change From Baseline in Average Total Ostomy Output at Last Visit During Non-Teduglutide Period

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    End point title
    Change From Baseline in Average Total Ostomy Output at Last Visit During Non-Teduglutide Period [19]
    End point description
    Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average ostomy output per day. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analyzed refer to the subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Last visit in NT (up to Month 39) (Each visit= 12 weeks)
    Notes
    [19] - 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 comparision analyses were performed for this endpoint.
    End point values
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide /Non-teduglutide Treatment (TED/NTT) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    0 [20]
    0 [21]
    0 [22]
    2
    Units: mL/kg/day
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    23.89 ± 37.835
    Notes
    [20] - Data was not collected and analysed at this time point, for this respective arm.
    [21] - Data was not collected and analysed at this time point, for this respective arm.
    [22] - Data was not collected and analysed at this time point, for this respective arm.
    No statistical analyses for this end point

    Primary: Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment Period [23] [24]
    End point description
    Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. Average daily fecal output was summarized the average typical stool form score using Bristol Stool Form Scale. Average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). Typical Stool Form based on Bristol Stool Form Scale: 1 - Separate hard lumps, hard to pass, 2 - Sausage-shaped, but lumpy, 3 - Like a sausage but with cracks on the surface, 4- Like a sausage or snake, smooth and soft, 5- Soft blobs with clear-cut edges, 6- Fluffy pieces with ragged edges, a mushy stool, 7- Watery, no solid pieces. Entirely liquid. Analyis was planned based on safety population. Here, number of subjects analyzed refer to the subjects evaluable for this endpoint. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Primary
    End point timeframe
    Baseline, EOT of last cycle (Up to Month 36) (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [23] - 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 comparision analyses were performed for this endpoint.
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    0 [25]
    32
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    ±
    -0.54 ± 0.977
    Notes
    [25] - Data was not collected and analysed at this time point, for this respective arm.
    No statistical analyses for this end point

    Primary: Change From Baseline in Average Bristol Stool Form Score at Last Visit During Non-Teduglutide Period

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    End point title
    Change From Baseline in Average Bristol Stool Form Score at Last Visit During Non-Teduglutide Period [26]
    End point description
    Fecal output was recorded over a 48 hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. Average daily fecal output was summarized separately the average typical stool form score using Bristol Stool Form Scale. Average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). Typical Stool Form based on Bristol Stool Form Scale: 1- Separate hard lumps, hard to pass, 2- Sausage-shaped, but lumpy, 3- Like a sausage but with cracks on the surface, 4 - Like a sausage or snake, smooth and soft, 5- Soft blobs with clear-cut edges, 6- Fluffy pieces with ragged edges, a mushy stool, 7- Watery, no solid pieces entirely liquid. Analysis were performed by safety population. Number of subjects analysed refer to the subjects evaluable for this endpoint. Here, '99999' indicates standard deviation was not estimated as only single subject was analysed.
    End point type
    Primary
    End point timeframe
    Baseline, Last visit in NT (up to Month 39) (Each visit= 12 weeks)
    Notes
    [26] - 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 comparision analyses were performed for this endpoint.
    End point values
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide /Non-teduglutide Treatment (TED/NTT) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    4
    0 [27]
    1
    14
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    -0.25 ± 0.500
    ±
    0.00 ± 99999
    -0.08 ± 0.583
    Notes
    [27] - Data was not collected and analysed at this time point, for this respective arm.
    No statistical analyses for this end point

    Primary: Number of Subjects With Positive Specific Antibodies

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    End point title
    Number of Subjects With Positive Specific Antibodies [28] [29]
    End point description
    Number of subjects with positive specific antibodies to teduglutide were used to summarize the presence of antibodies. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analyzed refer to the subjects evaluable for this endpoint. Data was planned to be collected and analysed for NTT/TED, TED/NTT and TED/TED arms only.
    End point type
    Primary
    End point timeframe
    Baseline up to EOS (Up to Month 46)
    Notes
    [28] - 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 comparision analyses were performed for this endpoint.
    [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide /Non-teduglutide Treatment (TED/NTT) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    1
    40
    Units: Subjects
    2
    0
    10
    No statistical analyses for this end point

    Primary: Change From Baseline in Body Weight Z-score at EOT of Last Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline in Body Weight Z-score at EOT of Last Cycle During Teduglutide Treatment Period [30] [31]
    End point description
    Body weight was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analyzed refer to the subjects evaluable for this endpoint. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Primary
    End point timeframe
    Baseline, EOT of last cycle (Up to Month 36) (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [30] - 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 comparision analyses were performed for this endpoint.
    [31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    2
    43
    Units: Z-score
        arithmetic mean (standard deviation)
    0.087 ± 0.422
    -0.164 ± 0.951
    No statistical analyses for this end point

    Primary: Change From Baseline in Body Weight Z-score at Last Visit During Non-Teduglutide Period

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    End point title
    Change From Baseline in Body Weight Z-score at Last Visit During Non-Teduglutide Period [32]
    End point description
    Body weight was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analyzed refer to the subjects evaluable for this endpoint. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed for the specified arm. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Primary
    End point timeframe
    Baseline, Last visit in NT (up to Month 39) (Each visit= 12 weeks)
    Notes
    [32] - 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 comparision analyses were performed for this endpoint.
    End point values
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide /Non-teduglutide Treatment (TED/NTT) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    1
    1
    19
    Units: Z-score
        arithmetic mean (standard deviation)
    -0.489 ± 0.542
    -0.132 ± 99999
    0.013 ± 99999
    -0.363 ± 0.657
    No statistical analyses for this end point

    Primary: Change From Baseline in Height Z-score at EOT of Last Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline in Height Z-score at EOT of Last Cycle During Teduglutide Treatment Period [33] [34]
    End point description
    Height was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analyzed refer to the subjects evaluable for this endpoint. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Primary
    End point timeframe
    Baseline, EOT of last cycle (Up to Month 36) (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [33] - 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 comparision analyses were performed for this endpoint.
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    2
    27
    Units: Z-score
        arithmetic mean (standard deviation)
    0.118 ± 0.968
    -0.277 ± 0.797
    No statistical analyses for this end point

    Primary: Change From Baseline in Height Z-score at Last Visit During Non-Teduglutide Period

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    End point title
    Change From Baseline in Height Z-score at Last Visit During Non-Teduglutide Period [35]
    End point description
    Height was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analyzed refer to the subjects evaluable for this endpoint. 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, Last visit in NT (up to Month 39) (Each visit= 12 weeks)
    Notes
    [35] - 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 comparision analyses were performed for this endpoint.
    End point values
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide /Non-teduglutide Treatment (TED/NTT) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    1
    1
    18
    Units: Z-score
        arithmetic mean (standard deviation)
    -0.518 ± 0.451
    -0.770 ± 99999
    0.220 ± 99999
    -0.132 ± 0.466
    No statistical analyses for this end point

    Primary: Change From Baseline in Head Circumference Z-score at EOT of Last Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline in Head Circumference Z-score at EOT of Last Cycle During Teduglutide Treatment Period [36] [37]
    End point description
    Head circumference was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analyzed refer to the subjects evaluable for this endpoint. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Primary
    End point timeframe
    Baseline, EOT of last cycle (Up to Month 36) (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [36] - 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 comparision analyses were performed for this endpoint.
    [37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    0 [38]
    2
    Units: Z-score
        arithmetic mean (standard deviation)
    ±
    -0.727 ± 0.440
    Notes
    [38] - Data was not collected and analysed at this time point, for this respective arm.
    No statistical analyses for this end point

    Primary: Change From Baseline in Head Circumference Z-score at Last Visit During Non-Teduglutide Period

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    End point title
    Change From Baseline in Head Circumference Z-score at Last Visit During Non-Teduglutide Period [39]
    End point description
    Head circumference was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analyzed refer to the subjects evaluable for this endpoint. 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, Last visit in NT (up to Month 39) (Each visit= 12 weeks)
    Notes
    [39] - 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 comparision analyses were performed for this endpoint.
    End point values
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide /Non-teduglutide Treatment (TED/NTT) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    0 [40]
    0 [41]
    0 [42]
    1
    Units: Z-score
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    -0.309 ± 99999
    Notes
    [40] - Data was not collected and analysed at this time point, for this respective arm.
    [41] - Data was not collected and analysed at this time point, for this respective arm.
    [42] - Data was not collected and analysed at this time point, for this respective arm.
    No statistical analyses for this end point

    Primary: Change From Baseline in Body Mass Index (BMI) Z-score at EOT of Last Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline in Body Mass Index (BMI) Z-score at EOT of Last Cycle During Teduglutide Treatment Period [43] [44]
    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. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analyzed refer to the subjects evaluable for this endpoint. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Primary
    End point timeframe
    Baseline, EOT of last cycle (Up to Month 36) (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [43] - 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 comparision analyses were performed for this endpoint.
    [44] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    2
    43
    Units: Z-score
        arithmetic mean (standard deviation)
    0.215 ± 0.142
    0.035 ± 0.904
    No statistical analyses for this end point

    Primary: Change From Baseline in Body Mass Index (BMI) Z-score at Last Visit During Non-Teduglutide Period

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    End point title
    Change From Baseline in Body Mass Index (BMI) Z-score at Last Visit During Non-Teduglutide Period [45]
    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. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analyzed refer to the subjects evaluable for this endpoint. 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, Last visit in NT (up to Month 39) (Each visit= 12 weeks)
    Notes
    [45] - 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 comparision analyses were performed for this endpoint.
    End point values
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide /Non-teduglutide Treatment (TED/NTT) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    1
    1
    19
    Units: Z-score
        arithmetic mean (standard deviation)
    -0.545 ± 1.335
    0.791 ± 99999
    -0.564 ± 99999
    -0.148 ± 0.555
    No statistical analyses for this end point

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

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    End point title
    Number of Subjects Who Achieved At least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment Period [46]
    End point description
    Number of subjects who achieved at least 20%, 50%, and 75% reduction from baseline in diary PS volume at EOT of last cycle during teduglutide treatment period was reported. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, "n=number analysed" refer to subjects who were evaluable at given categories. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only
    End point type
    Secondary
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [46] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    50
    Units: Subjects
        EOT of Cycle 1: >= 20% Reduction (n=3, 50)
    1
    29
        EOT of Cycle 1: >= 50% Reduction (n=3, 50)
    0
    13
        EOT of Cycle 1: >= 75% Reduction (n=3, 50)
    0
    7
        EOT of Cycle 2: >= 20% Reduction (n=2, 43)
    1
    29
        EOT of Cycle 2: >= 50% Reduction (n=2, 43)
    0
    17
        EOT of Cycle 2: >= 75% Reduction (n=2, 43)
    0
    9
        EOT of Cycle 3: >= 20% Reduction (n=2, 33)
    2
    22
        EOT of Cycle 3: >= 50% Reduction (n=2, 33)
    0
    14
        EOT of Cycle 3: >= 75% Reduction (n=2, 33)
    0
    6
        EOT of Cycle 4: >= 20% Reduction (n=1, 27)
    1
    20
        EOT of Cycle 4: >= 50% Reduction (n=1, 27)
    1
    13
        EOT of Cycle 4: >= 75% Reduction (n=1, 27)
    0
    7
        EOT of Cycle 5: >= 20% Reduction (n=1, 20)
    1
    15
        EOT of Cycle 5: >= 50% Reduction (n=1, 20)
    1
    13
        EOT of Cycle 5: >= 75% Reduction (n=1, 20)
    0
    6
        EOT of Cycle 6: >= 20% Reduction (n=0, 3)
    0
    2
        EOT of Cycle 6: >= 50% Reduction (n=0, 3)
    0
    2
        EOT of Cycle 6: >= 75% Reduction (n=0, 3)
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects Who Achieved At least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment Period

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    End point title
    Number of Subjects Who Achieved At least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment Period [47]
    End point description
    Number of subjects who achieved at least 20%, 50%, and 75% reduction from baseline in prescribed PS volume at EOT of east cycle during teduglutide treatment period was reported. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, "n=number analysed" refer to subjects who were evaluable at given categories. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Secondary
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [47] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    50
    Units: Subjects
        EOT of Cycle 1: >= 20% Reduction in PS (n=3, 50)
    2
    35
        EOT of Cycle 1: >= 50% Reduction in PS (n=3, 50)
    0
    18
        EOT of Cycle 1: >= 75% Reduction in PS (n=3, 50)
    0
    9
        EOT of Cycle 2: >= 20% Reduction in PS (n=2, 43)
    2
    31
        EOT of Cycle 2: >= 50% Reduction in PS (n=2, 43)
    2
    18
        EOT of Cycle 2: >= 75% Reduction in PS (n=2, 43)
    1
    11
        EOT of Cycle 3: >= 20% Reduction in PS (n=2, 33)
    2
    24
        EOT of Cycle 3: >= 50% Reduction in PS (n=2, 33)
    1
    14
        EOT of Cycle 3: >= 75% Reduction in PS (n=2, 33)
    1
    7
        EOT of Cycle 4: >= 20% Reduction in PS (n=1, 27)
    1
    21
        EOT of Cycle 4: >= 50% Reduction in PS (n=1, 27)
    1
    13
        EOT of Cycle 4: >= 75% Reduction in PS (n=1, 27)
    0
    7
        EOT of Cycle 5: >= 20% Reduction in PS (n=1, 20)
    1
    17
        EOT of Cycle 5: >= 50% Reduction in PS (n=1, 20)
    1
    12
        EOT of Cycle 5: >= 75% Reduction in PS (n=1, 20)
    0
    6
        EOT of Cycle 6: >= 20% Reduction in PS (n=0, 3)
    0
    2
        EOT of Cycle 6: >= 50% Reduction in PS (n=0, 3)
    0
    2
        EOT of Cycle 6: >= 75% Reduction in PS (n=0, 3)
    0
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment Period [48]
    End point description
    Change from baseline in diary PS volume at EOT of each cycle during teduglutide treatment period was reported. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analysed refer to the subjects evaluable for this endpoint and "n=number analysed" refer to subjects evaluable at given categories. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed at specified time point and '9999' indicates that data was not estimated as no subject was analysed at specified time point. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Secondary
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [48] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    39
    Units: mL/kg/day
    arithmetic mean (standard deviation)
        Change at EOT of Cycle 1 (n=3, 39)
    -14.87 ± 4.574
    -22.63 ± 18.125
        Change at EOT of Cycle 2 (n=2, 38)
    -8.98 ± 10.490
    -25.75 ± 22.480
        Change at EOT of Cycle 3 (n=3, 29)
    -34.81 ± 15.314
    -32.01 ± 28.837
        Change at EOT of Cycle 4 (n=1, 25)
    -57.45 ± 99999
    -32.61 ± 24.639
        Change at EOT of Cycle 5 (n=1, 19)
    -56.90 ± 99999
    -38.76 ± 21.148
        Change at EOT of Cycle 6 (n=0, 3)
    9999 ± 9999
    -40.51 ± 24.833
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment Period [49]
    End point description
    Percent change from baseline in diary PS volume at EOT of each cycle during teduglutide treatment period was reported. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analysed refer to the subjects evaluable for this endpoint and "n=number analysed" refer to subjects evaluable at given categories. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed at specified time point and '9999' indicates that data was not estimated as no subject was analysed at specified time point. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Secondary
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    39
    Units: Percent change
    arithmetic mean (standard deviation)
        Percent change at EOT of Cycle 1 (n=3, 39)
    -23.23 ± 15.103
    -41.88 ± 34.100
        Percent change at EOT of Cycle 2 (n=2, 38)
    -13.29 ± 16.826
    -45.67 ± 38.377
        Percent change at EOT of Cycle 3 (n=2, 29)
    -38.66 ± 2.603
    -46.62 ± 37.756
        Percent change at EOT of Cycle 4 (n=1, 25)
    -50.99 ± 99999
    -51.28 ± 36.364
        Percent change at EOT of Cycle 5 (n=1, 19)
    -50.50 ± 99999
    -58.86 ± 33.522
        Percent change at EOT of Cycle 6 (n=0, 3)
    9999 ± 9999
    -52.87 ± 32.722
    No statistical analyses for this end point

    Secondary: Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment Period [50]
    End point description
    Change from baseline in prescribed PS volume at EOT of each cycle during teduglutide treatment period was reported. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, "n=number analysed" refer to subjects who were evaluable at given categories. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed at specified time point and '9999' indicates that data was not estimated as no subject was analysed at specified time point. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Secondary
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    50
    Units: mL/kg/day
    arithmetic mean (standard deviation)
        Change at EOT of Cycle 1 (n=3, 50)
    -22.57 ± 13.957
    -20.87 ± 20.957
        Change at EOT of Cycle 2 (n=2, 43)
    -65.88 ± 12.621
    -24.24 ± 24.914
        Change at EOT of Cycle 3 (n=2, 33)
    -58.82 ± 4.022
    -30.53 ± 26.449
        Change at EOT of Cycle 4 (n=1, 27)
    -68.72 ± 99999
    -34.53 ± 23.849
        Change at EOT of Cycle 5 (n=1, 20)
    -68.99 ± 99999
    -37.78 ± 22.850
        Change at EOT of Cycle 6 (n=0, 3)
    9999 ± 9999
    -39.10 ± 24.154
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment Period [51]
    End point description
    Percent change from baseline in prescribed PS volume at EOT of each cycle during teduglutide treatment period was reported. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, "n=number analysed" refer to subjects who were evaluable at given categories. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed at specified time point and '9999' indicates that data was not estimated as no subject was analysed at specified time point. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Secondary
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [51] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    50
    Units: Percent change
    arithmetic mean (standard deviation)
        Percent change at EOT of Cycle 1 (n=3, 50)
    -28.82 ± 12.660
    -34.43 ± 52.810
        Percent change at EOT of Cycle 2 (n=2, 43)
    -73.03 ± 18.304
    -42.38 ± 42.375
        Percent change at EOT of Cycle 3 (n=2, 33)
    -67.01 ± 24.723
    -44.07 ± 36.002
        Percent change at EOT of Cycle 4 (n=1, 27)
    -55.20 ± 99999
    -52.78 ± 33.033
        Percent change at EOT of Cycle 5 (n=1, 20)
    -55.42 ± 99999
    -57.42 ± 34.250
        Percent change at EOT of Cycle 6 (n=0, 3)
    9999 ± 9999
    -52.62 ± 33.377
    No statistical analyses for this end point

    Secondary: Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment Period [52]
    End point description
    Change from baseline in diary PS caloric intake at EOT of each cycle during teduglutide treatment period was reported. Here, kilo-calories per kilogram per day was abbreviated as (kcal/kg/day). The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analysed refer to the subjects evaluable for this endpoint and "n=number analysed" refer to subjects evaluable at given categories. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed at specified time point and '9999' indicates that data was not estimated as no subject was analysed at specified time point. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Secondary
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    39
    Units: kcal/kg/day
    arithmetic mean (standard deviation)
        Change at EOT of Cycle 1 (n=3, 39)
    -16.95 ± 15.141
    -17.40 ± 13.401
        Change at EOT of Cycle 2 (n=2, 38)
    -10.46 ± 0.023
    -18.71 ± 16.722
        Change at EOT of Cycle 3 (n=2, 29)
    -20.77 ± 0.206
    -22.09 ± 18.009
        Change at EOT of Cycle 4 (n=1, 25)
    -34.01 ± 99999
    -24.67 ± 18.859
        Change at EOT of Cycle 5 (n=1, 19)
    -33.68 ± 99999
    -30.20 ± 13.754
        Change at EOT of Cycle 6 (n=0, 3)
    9999 ± 9999
    -34.46 ± 20.080
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment Period [53]
    End point description
    Percent change from baseline in diary PS Caloric intake at EOT of each cycle during teduglutide treatment period was reported. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analysed refer to the subjects evaluable for this endpoint and "n=number analysed" refer to subjects evaluable at given categories. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed at specified time point and '9999' indicates that data was not estimated as no subject was analysed at specified time point. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Secondary
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [53] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    39
    Units: Percent change
    arithmetic mean (standard deviation)
        Percent change at EOT of Cycle 1 (n=3, 39)
    -35.21 ± 31.088
    -45.91 ± 35.484
        Percent change at EOT of Cycle 2 (n=2, 38)
    -14.63 ± 1.162
    -48.66 ± 38.282
        Percent change at EOT of Cycle 3 (n=2, 29)
    -29.03 ± 2.083
    -46.75 ± 38.042
        Percent change at EOT of Cycle 4 (n=1, 25)
    -50.31 ± 99999
    -53.23 ± 37.611
        Percent change at EOT of Cycle 5 (n=1, 19)
    -49.81 ± 99999
    -64.30 ± 30.289
        Percent change at EOT of Cycle 6 (n=0, 3)
    9999 ± 9999
    -50.89 ± 25.667
    No statistical analyses for this end point

    Secondary: Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment Period [54]
    End point description
    Change from baseline in prescribed PS caloric intake at EOT of each cycle during teduglutide treatment period was reported. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analysed refer to the subjects evaluable for this endpoint and "n=number analysed" refer to subjects evaluable at given categories. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed at specified time point and '9999' indicates that data was not estimated as no subject was analysed at specified time point. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Secondary
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [54] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    49
    Units: kcal/kg/day
    arithmetic mean (standard deviation)
        Change at EOT of Cycle 1 (n=3, 49)
    -16.94 ± 15.187
    -15.80 ± 17.337
        Change at EOT of Cycle 2 (n=2, 42)
    -37.91 ± 38.003
    -16.00 ± 18.918
        Change at EOT of Cycle 3 (n=2, 32)
    -44.01 ± 27.532
    -20.18 ± 15.633
        Change at EOT of Cycle 4 (n=1, 27)
    -34.59 ± 99999
    -24.48 ± 15.899
        Change at EOT of Cycle 5 (n=1, 20)
    -34.76 ± 99999
    -27.83 ± 15.311
        Change at EOT of Cycle 6 (n=0, 3)
    9999 ± 9999
    -33.30 ± 19.205
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment Period [55]
    End point description
    Percent change from baseline in prescribed PS caloric intake at EOT of each cycle during teduglutide treatment period was reported. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analysed refer to the subjects evaluable for this endpoint and "n=number analysed" refer to subjects evaluable at given categories. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed at specified time point and '9999' indicates that data was not estimated as no subject was analysed at specified time point. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Secondary
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    49
    Units: Percent change
    arithmetic mean (standard deviation)
        Percent change at EOT of Cycle 1 (n=3, 49)
    -34.79 ± 31.100
    -40.67 ± 39.607
        Percent change at EOT of Cycle 2 (n=2, 42)
    -50.00 ± 47.944
    -42.75 ± 45.563
        Percent change at EOT of Cycle 3 (n=2, 32)
    -59.00 ± 32.825
    -44.74 ± 35.274
        Percent change at EOT of Cycle 4 (n=1, 27)
    -50.45 ± 99999
    -54.32 ± 32.153
        Percent change at EOT of Cycle 5 (n=1, 20)
    -50.69 ± 99999
    -59.49 ± 30.789
        Percent change at EOT of Cycle 6 (n=0, 3)
    9999 ± 9999
    -50.67 ± 26.310
    No statistical analyses for this end point

    Secondary: Number of Subjects Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Number of Subjects Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment Period [56]
    End point description
    Number of subjects who achieved at least 100% reduction in complete weaning of PS volume at EOT of each cycle during teduglutide treatment period was reported. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, "n=number analysed" refer to subjects who were evaluable at given categories. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Secondary
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [56] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    50
    Units: Subjects
        EOT of Cycle 1 (n=3, 50)
    0
    7
        EOT of Cycle 2 (n=2, 43)
    0
    8
        EOT of Cycle 3 (n=2, 33)
    0
    6
        EOT of Cycle 4 (n=1, 27)
    0
    6
        EOT of Cycle 5 (n=1, 20)
    0
    6
        EOT of Cycle 6 (n=0, 3)
    0
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hours per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline in Hours per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment Period [57]
    End point description
    Change from baseline in hours per day of diary PS usage at EOT of each cycle during teduglutide treatment period was reported. Hours per day of diary PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit). The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analysed refer to the subjects evaluable for this endpoint and "n=number analysed" refer to subjects evaluable at given categories. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed at specified time point and '9999' indicates that data was not estimated as no subject was analysed at specified time point. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Secondary
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [57] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    39
    Units: hours/day
    arithmetic mean (standard deviation)
        Change at EOT of Cycle 1 (n=3, 39)
    -0.57 ± 0.990
    -3.58 ± 3.750
        Change at EOT of Cycle 2 (n=2, 28)
    -1.71 ± 2.424
    -3.55 ± 4.497
        Change at EOT of Cycle 3 (n=2, 29)
    -3.57 ± 2.222
    -4.19 ± 5.036
        Change at EOT of Cycle 4 (n=1, 25)
    -4.00 ± 99999
    -4.83 ± 5.069
        Change at EOT of Cycle 5 (n=1, 19)
    -4.00 ± 99999
    -5.64 ± 5.392
        Change at EOT of Cycle 6 (n=0, 3)
    9999 ± 9999
    -5.14 ± 4.536
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Hours per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Percent Change From Baseline in Hours per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment Period [58]
    End point description
    Percent change from baseline in hours per day of diary PS usage at EOT of each cycle during teduglutide treatment period was reported. Hours per day of diary PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit). Safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Number of subjects analysed refer to the subjects evaluable for this endpoint and "n=number analysed" refer to subjects evaluable at given categories. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed at specified time point and '9999' indicates that data was not estimated as no subject was analysed at specified time point. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Secondary
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [58] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    39
    Units: Percent change
    arithmetic mean (standard deviation)
        Percent change at EOT of Cycle 1 (n=3, 39)
    -4.76 ± 8.248
    -33.43 ± 35.645
        Percent change at EOT of Cycle 2 (n=2, 38)
    -14.29 ± 20.203
    -34.12 ± 41.982
        Percent change at EOT of Cycle 3 (n=2, 29)
    -26.98 ± 22.448
    -35.11 ± 41.822
        Percent change at EOT of Cycle 4 (n=1, 25)
    -22.22 ± 99999
    -40.68 ± 42.255
        Percent change at EOT of Cycle 5 (n=1, 19)
    -22.22 ± 99999
    -47.07 ± 44.248
        Percent change at EOT of Cycle 6 (n=0, 3)
    9999 ± 9999
    -42.86 ± 37.796
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hours per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline in Hours per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment Period [59]
    End point description
    Change from baseline in hours per day of prescribed PS usage at EOT of each cycle during teduglutide treatment period was reported. Hours per day of prescribed PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit). The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, "n=number analysed" refer to subjects who were evaluable at given categories. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed at specified time point and '9999' indicates that data was not estimated as no subject was analysed at specified time point. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Secondary
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [59] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    50
    Units: hours/day
    arithmetic mean (standard deviation)
        Change at EOT of Cycle 1 (n=3, 50)
    0.00 ± 0.000
    -2.60 ± 4.279
        Change at EOT of Cycle 2 (n=2, 43)
    -3.00 ± 4.243
    -2.78 ± 5.479
        Change at EOT of Cycle 3 (n=2, 33)
    -1.00 ± 1.414
    -2.79 ± 5.400
        Change at EOT of Cycle 4 (n=1, 27)
    -4.00 ± 99999
    -3.43 ± 5.849
        Change at EOT of Cycle 5 (n=1, 20)
    -4.00 ± 99999
    -3.93 ± 6.070
        Change at EOT of Cycle 6 (n=0, 3)
    9999 ± 9999
    0.00 ± 0.000
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Hours per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Percent Change From Baseline in Hours per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment Period [60]
    End point description
    Percent change from baseline in hours per day of prescribed PS usage at EOT of each cycle during teduglutide treatment period was reported. Hours per day of prescribed PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit). Safety population; all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analysed refer to subjects evaluable for this endpoint and "n=number analysed" refer to subjects evaluable at given categories. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed at specified time point and '9999' indicates that data was not estimated as no subject was analysed at specified time point. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Secondary
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [60] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    49
    Units: Percent change
    arithmetic mean (standard deviation)
        Percent change at EOT of Cycle 1 (n=3, 49)
    0.00 ± 0.000
    -21.27 ± 34.449
        Percent change at EOT of Cycle 2 (n=2, 42)
    -16.67 ± 23.570
    -22.75 ± 47.101
        Percent change at EOT of Cycle 3 (n=2, 32)
    -5.56 ± 7.857
    -20.64 ± 40.735
        Percent change at EOT of Cycle 4 (n=1, 26)
    -22.22 ± 99999
    -25.47 ± 43.906
        Percent change at EOT of Cycle 5 (n=1, 19)
    -22.22 ± 99999
    -32.28 ± 48.126
        Percent change at EOT of Cycle 6 (n=0, 3)
    9999 ± 9999
    0.00 ± 0.000
    No statistical analyses for this end point

    Secondary: Change From Baseline in Days per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline in Days per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment Period [61]
    End point description
    Change from baseline in days per week of diary PS usage at EOT of each cycle during teduglutide treatment period was reported. Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analysed refer to the subjects evaluable for this endpoint and "n=number analysed" refer to subjects evaluable at given categories. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed at specified time point and '9999' indicates that data was not estimated as no subject was analysed at specified time point. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Secondary
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [61] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    39
    Units: Days/week
    arithmetic mean (standard deviation)
        Change at EOT of Cycle 1 (n=3, 39)
    -0.33 ± 0.577
    -1.41 ± 2.432
        Change at EOT of Cycle 2 (n=2, 38)
    -1.00 ± 1.414
    -1.76 ± 2.508
        Change at EOT of Cycle 3 (n=2, 29)
    -1.50 ± 2.121
    -2.13 ± 2.756
        Change at EOT of Cycle 4 (n=1, 25)
    0.00 ± 99999
    -2.36 ± 2.956
        Change at EOT of Cycle 5 (n=1, 19)
    0.00 ± 99999
    -2.70 ± 3.107
        Change at EOT of Cycle 6 (n=0, 3)
    9999 ± 9999
    -3.00 ± 2.646
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Days per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Percent Change From Baseline in Days per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment Period [62]
    End point description
    Percent change from baseline in days per week of diary PS usage at EOT of each cycle during teduglutide treatment period was reported. Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7. Safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, number of subjects analysed refer to the subjects evaluable for this endpoint and "n=number analysed" refer to subjects evaluable at given categories. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed at specified time point and '9999' indicates that data was not estimated as no subject was analysed at specified time point. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Secondary
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [62] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    39
    Units: Percent change
    arithmetic mean (standard deviation)
        Percent change at EOT of Cycle 1 (n=3, 39)
    -4.76 ± 8.248
    -23.40 ± 39.994
        Percent change at EOT of Cycle 2 (n=2, 38)
    -14.29 ± 20.203
    -29.07 ± 41.805
        Percent change at EOT of Cycle 3 (n=2, 29)
    -21.43 ± 30.305
    -31.37 ± 41.530
        Percent change at EOT of Cycle 4 (n=1, 25)
    0.00 ± 99999
    -34.66 ± 44.475
        Percent change at EOT of Cycle 5 (n=1, 19)
    0.00 ± 99999
    -39.50 ± 47.024
        Percent change at EOT of Cycle 6 (n=0, 3)
    9999 ± 9999
    -42.86 ± 37.796
    No statistical analyses for this end point

    Secondary: Change From Baseline in Days per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline in Days per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment Period [63]
    End point description
    Change from baseline in days per week of prescribed PS usage at EOT of each cycle during teduglutide treatment period was reported. Days per week of prescribed PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7. The safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, "n=number analysed" refer to subjects who were evaluable at given categories. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed at specified time point and '9999' indicates that data was not estimated as no subject was analysed at specified time point. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Secondary
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [63] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    50
    Units: Days/week
    arithmetic mean (standard deviation)
        Change at EOT of Cycle 1 (n=3, 50)
    -0.33 ± 0.577
    -1.42 ± 2.251
        Change at EOT of Cycle 2 (n=2, 43)
    -1.00 ± 1.414
    -1.65 ± 2.399
        Change at EOT of Cycle 3 (n=2, 33)
    -1.50 ± 2.121
    -1.85 ± 2.623
        Change at EOT of Cycle 4 (n=1, 27)
    0.00 ± 99999
    -2.15 ± 2.852
        Change at EOT of Cycle 5 (n=1, 20)
    0.00 ± 99999
    -2.75 ± 3.041
        Change at EOT of Cycle 6 (n=0, 3)
    9999 ± 9999
    -3.00 ± 2.646
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Days per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Percent Change From Baseline in Days per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment Period [64]
    End point description
    Percent change from baseline in days per week of prescribed PS usage at EOT of each cycle during teduglutide treatment period was reported. Days per week of prescribed PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7. Safety population consisted all enrolled subjects who provided informed consent and met all the inclusion criteria. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed at specified time point and '9999' indicates that data was not estimated as no subject was analysed at specified time point. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Secondary
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [64] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    50
    Units: Percent change
    arithmetic mean (standard deviation)
        Percent change at EOT of Cycle 1 (n=3, 50)
    -4.76 ± 8.248
    -23.18 ± 36.926
        Percent change at EOT of Cycle 2 (n=2, 43)
    -14.29 ± 20.203
    -27.41 ± 40.209
        Percent change at EOT of Cycle 3 (n=2, 33)
    -21.43 ± 30.305
    -27.58 ± 40.258
        Percent change at EOT of Cycle 4 (n=1, 27)
    0.00 ± 99999
    -32.12 ± 43.730
        Percent change at EOT of Cycle 5 (n=1, 20)
    0.00 ± 99999
    -40.86 ± 46.839
        Percent change at EOT of Cycle 6 (n=0, 3)
    9999 ± 9999
    -42.86 ± 37.796
    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 EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment Period [65]
    End point description
    PedsQL GCS was designed to measure health-related quality of life in pediatric subjects and adolescents (2 to 18 years of age). It encompasses 4 dimensions of functioning (physical [8 items], emotional [5 items], social [5 items], school [3 items]). Age groups were: Toddler (2-4 years), Young pediatric (5-7 years), Pediatric (8-12 years), and Teens (13-18 years). Depending on the subjects age, the questionnaire may be completed by parent/caregiver as appropriate. For Toddler group, PedsQL GCS consisted of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, PedsQL GCS consisted of 23 items, with a 3-point Likert scale (0, 2, 4) for the young pediatric, and a 5-point Likert scale for the pediatric and teens groups. Scores are transformed on a scale from 0 to 100 where 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life. Analysis: safety population. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [65] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    2
    42
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Physical Functioning: EOT of Cycle 1 (n=2, 42)
    -21.88 ± 8.839
    -2.44 ± 22.323
        Physical Functioning: EOT of Cycle 2 (n=1, 34)
    -18.75 ± 99999
    4.69 ± 22.327
        Physical Functioning: EOT of Cycle 3 (n=1, 28)
    -18.75 ± 99999
    -5.80 ± 27.093
        Physical Functioning: EOT of Cycle 4 (n=1, 22)
    -9.38 ± 99999
    4.12 ± 20.872
        Physical Functioning: EOT of Cycle 5 (n=1, 11)
    -15.63 ± 99999
    4.83 ± 20.840
        Physical Functioning: EOT of Cycle 6 (n=0, 0)
    9999 ± 9999
    9999 ± 9999
        Emotional Functioning: EOT of Cycle 1 (n=2, 41)
    -7.50 ± 10.607
    -2.07 ± 16.807
        Emotional Functioning: EOT of Cycle 2 (n=1, 34)
    5.00 ± 99999
    0.88 ± 15.249
        Emotional Functioning: EOT of Cycle 3 (n=1, 28)
    -15.00 ± 99999
    -0.36 ± 20.680
        Emotional Functioning: EOT of Cycle 4 (n=1, 22)
    5.00 ± 99999
    1.82 ± 22.811
        Emotional Functioning: EOT of Cycle 5 (n=1, 11)
    0.00 ± 99999
    1.36 ± 23.674
        Emotional Functioning: EOT of Cycle 6 (n=0, 0)
    9999 ± 9999
    9999 ± 9999
        Social Functioning: EOT of Cycle 1 (n=2, 41)
    -12.50 ± 17.678
    0.49 ± 18.262
        Social Functioning: EOT of Cycle 2 (n=1, 34)
    -25.00 ± 99999
    5.29 ± 20.484
        Social Functioning: EOT of Cycle 3 (n=1, 28)
    -30.00 ± 99999
    2.14 ± 24.662
        Social Functioning: EOT of Cycle 4 (n=1, 22)
    -15.00 ± 99999
    3.86 ± 23.193
        Social Functioning: EOT of Cycle 5 (n=1, 11)
    -15.00 ± 99999
    2.95 ± 20.458
        Social Functioning: EOT of Cycle 6 (n=0, 0)
    9999 ± 9999
    9999 ± 9999
        School Functioning: EOT of Cycle 1 (n=0, 31)
    9999 ± 9999
    3.33 ± 25.111
        School Functioning: EOT of Cycle 2 (n=0, 25)
    9999 ± 9999
    6.93 ± 27.096
        School Functioning: EOT of Cycle 3 (n=0, 20)
    9999 ± 9999
    1.17 ± 33.804
        School Functioning: EOT of Cycle 4 (n=0, 15)
    9999 ± 9999
    9.89 ± 25.233
        School Functioning: EOT of Cycle 5 (n=0, 8)
    9999 ± 9999
    8.33 ± 23.721
        School Functioning: EOT of Cycle 6 (n=0, 0)
    9999 ± 9999
    9999 ± 9999
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Period

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    End point title
    Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Period
    End point description
    PedsQL GCS was designed to measure health-related quality of life in pediatric subjects and adolescents (2 to 18 years of age). It encompasses 4 dimensions of functioning (physical [8 items], emotional [5 items], social [5 items], school [3 items]). Age groups were: Toddler (2-4 years), Young pediatric (5-7 years), Pediatric (8-12 years), and Teens (13-18 years). Depending on the subject’s age, the questionnaire may be completed by parent/caregiver as appropriate. For the Toddler group, the PedsQL GCS consisted of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consisted of 23 items, with a 3-point Likert scale (0, 2, 4) for the young pediatric, and a 5-point Likert scale for the pediatric and teens groups. Scores are transformed on a scale from 0 to 100 where 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life. Analysis: safety population. Here, "n=number analysed" refer to subjects evaluable at given categories.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Last visit in NT (up to Month 39) (Each visit= 12 weeks)
    End point values
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide /Non-teduglutide Treatment (TED/NTT) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    4
    1
    1
    14
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Physical Functioning: Last NT (n=4, 1, 1, 13)
    3.91 ± 10.636
    -3.13 ± 99999
    31.25 ± 99999
    13.56 ± 22.573
        Emotional Functioning: Last NT (n=4, 1, 1, 14)
    -2.50 ± 15.546
    -10.00 ± 99999
    0.00 ± 99999
    2.50 ± 23.101
        Social Functioning: Last NT (n=4, 1, 1, 13)
    0.00 ± 4.082
    -10.00 ± 99999
    -10.00 ± 99999
    7.31 ± 16.535
        School Functioning: Last NT (n=3, 0, 1, 9)
    11.67 ± 45.369
    9999 ± 9999
    0.00 ± 99999
    3.89 ± 25.954
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline In PedsQL Total Family Impact Module Score at EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline In PedsQL Total Family Impact Module Score at EOT of Each Cycle During Teduglutide Treatment Period [66]
    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 family impact score was calculated as the sum of all the items over the number of items answered on all the scales. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life. Analysis was performed based on safety population. Here, "n=number analysed" refer to subjects evaluable at given categories. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed at specified time point and '9999' indicates that data was not estimated as no subject was analysed at specified time point. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [66] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    43
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Change at EOT of Cycle 1 (n=3, 43)
    -10.65 ± 9.326
    1.55 ± 15.071
        Change at EOT of Cycle 2 (n=2, 34)
    -2.78 ± 3.928
    4.62 ± 18.250
        Change at EOT of Cycle 3 (n=2, 25)
    -5.56 ± 5.893
    0.20 ± 20.861
        Change at EOT of Cycle 4 (n=1, 22)
    2.78 ± 99999
    5.27 ± 21.637
        Change at EOT of Cycle 5 (n=1, 10)
    -13.19 ± 99999
    5.08 ± 16.152
        Change at EOT of Cycle 6 (n=0, 0)
    9999 ± 9999
    9999 ± 9999
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline In PedsQL Total Family Impact Module Score at Last Visit During Non-Teduglutide Period

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    End point title
    Change From Baseline In PedsQL Total Family Impact Module Score at Last Visit During Non-Teduglutide 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 family impact score was calculated as the sum of all the items over the number of items answered on all the scales. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life. Analysis was performed based on safety population. Here, number of subjects analysed refer to the subjects evaluable for this endpoint. Here, '99999' indicates that standard deviation was not estimated as only single subject was analysed for the specified arm.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Last visit in NT (up to Month 39) (Each visit= 12 weeks)
    End point values
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide /Non-teduglutide Treatment (TED/NTT) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    3
    1
    1
    15
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -3.47 ± 10.914
    -27.78 ± 99999
    -12.50 ± 99999
    6.44 ± 22.648
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment Period

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    End point title
    Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment Period [67]
    End point description
    PedsQL Gastrointestinal symptoms module was composed of 58 items, comprised of 10 different symptom scales that assess gastrointestinal symptom-related quality of life: food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea. Only the scales of food and drink limits (6 items) and diarrhea (7 items) was used in this study. Sub-scale score was calculated as the sum of the items over the number of items answered in the scale. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life. Analysis was performed based on safety population. Here, number of subjects analysed refer to the subjects evaluable for this endpoint and "n=number analysed" refer to subjects evaluable at given categories. Data was planned to be collected and analysed for NTT/TED, and TED/TED arm only.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks)
    Notes
    [67] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analysed for the reporting group of “Teduglutide” treatment period only.
    End point values
    Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    2
    39
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Food and Drink Limits: EOT of Cycle 1 (n=2, 39)
    -12.50 ± 17.678
    1.71 ± 31.250
        Food and Drink Limits: EOT of Cycle 2 (n=1, 31)
    -4.17 ± 99999
    9.41 ± 35.583
        Food and Drink Limits: EOT of Cycle 3 (n=1, 25)
    -4.17 ± 99999
    11.83 ± 36.178
        Food and Drink Limits: EOT of Cycle 4 (n=1, 22)
    12.50 ± 99999
    18.56 ± 33.227
        Food and Drink Limits: EOT of Cycle 5 (n=1, 10)
    0.00 ± 99999
    13.33 ± 25.215
        Food and Drink Limits: EOT of Cycle 6 (n=0, 0)
    9999 ± 9999
    9999 ± 9999
        Diarrhea: EOT of Cycle 1 (n=1, 36)
    0.00 ± 99999
    8.56 ± 21.309
        Diarrhea: EOT of Cycle 2 (n=1, 30)
    0.00 ± 99999
    10.00 ± 19.162
        Diarrhea: EOT of Cycle 3 (n=0, 23)
    9999 ± 9999
    11.49 ± 23.665
        Diarrhea: EOT of Cycle 4 (n=1, 20)
    -3.57 ± 99999
    8.57 ± 23.702
        Diarrhea: EOT of Cycle 5 (n=0, 9)
    9999 ± 9999
    5.56 ± 27.147
        Diarrhea: EOT of Cycle 6 (n=0, 0)
    9999 ± 9999
    9999 ± 9999
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline In PedsQL Gastrointestinal Symptoms Module at Last Visit During Non-Teduglutide Period

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    End point title
    Change From Baseline In PedsQL Gastrointestinal Symptoms Module at Last Visit During Non-Teduglutide Period
    End point description
    PedsQL gastrointestinal symptoms module was composed of 58 items, comprised of 10 different symptom scales that assess gastrointestinal symptom-related quality of life: food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea. Only the scales of food and drink limits (6 items) and diarrhea (7 items) was used in this study. Sub-scale score was calculated as the sum of the items over the number of items answered in the scale. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life. Analysis: safety population. Number of subjects analysed refer to the subjects evaluable for this endpoint and "n=number analysed" refer to subjects evaluable at given categories. '99999' indicates standard deviation was not estimated as only single subject was analysed for the specified arm.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Last visit in NT (up to Month 39) (Each visit= 12 weeks)
    End point values
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide /Non-teduglutide Treatment (TED/NTT) Teduglutide/Teduglutide Treatment (TED/TED)
    Number of subjects analysed
    4
    1
    1
    12
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Food and Drink Limits: Last NT (n=4,1,1,12)
    -7.29 ± 32.698
    -29.17 ± 99999
    -8.33 ± 99999
    5.35 ± 34.013
        Diarrhea: Last NT (n=4,0,1,10)
    -4.46 ± 4.494
    9999 ± 9999
    3.57 ± 99999
    1.70 ± 19.555
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of study drug administration up to follow-up (up to Month 46)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)
    Reporting group description
    Subjects who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in no-teduglutide period up to 39 months (Each visit =12 weeks of cycle up to 14 visits) in the study.

    Reporting group title
    Non-teduglutide/Teduglutide Treatment (NTT/TED)
    Reporting group description
    Subjects who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 36 months (Up to 6 Cycles [each Cycle 1 to 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks]).

    Reporting group title
    Teduglutide /Non-teduglutide Treatment (TED/NTT)
    Reporting group description
    Subjects who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in no-teduglutide period up to 39 months (Each visit =12 weeks of cycle up to 14 visits) in the study.

    Reporting group title
    Teduglutide/Teduglutide Treatment (TED/TED)
    Reporting group description
    Subjects who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 36 months (Up to 6 Cycles [each Cycle 1 to 4 = 28 weeks, Cycle 5 = 27 weeks, and Cycle 6 = 16 weeks]).

    Serious adverse events
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide /Non-teduglutide Treatment (TED/NTT) Teduglutide/Teduglutide Treatment (TED/TED)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 7 (57.14%)
    2 / 3 (66.67%)
    1 / 1 (100.00%)
    41 / 50 (82.00%)
         number of deaths (all causes)
    0
    0
    0
    2
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    Superior vena cava occlusion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Vena cava thrombosis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    General disorders and administration site conditions
    Complication associated with device
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Condition aggravated
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Granuloma
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    16 / 50 (32.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 31
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
    Femur fracture
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative ileus
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Procedural haemorrhage
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Vascular access complication
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Investigations
    Astrovirus test positive
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 50 (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
    Bacterial test positive
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Blood bilirubin increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Blood culture positive
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Enterovirus test positive
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Escherichia test positive
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Haemoglobin decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Atrial thrombosis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Cough
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Hypocapnia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Respiratory failure
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Nervous system disorders
    Cerebral ischaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Ischaemic stroke
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Lethargy
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
    Seizure
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Abdominal pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 50 (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
    Colonic haematoma
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Diarrhoea
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         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
    Enterocutaneous fistula
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Faecaloma
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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 haemorrhage
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Haematochezia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Ileus
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Ileus paralytic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 50 (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
    Intestinal dilatation
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 50 (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
    Mallory-Weiss syndrome
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Small intestinal stenosis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 50 (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
    Vomiting
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Cholelithiasis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         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
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Renal tubular acidosis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Product issues
    Device breakage
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    5 / 50 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         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
    Device expulsion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Device malfunction
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
    Device occlusion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    0 / 50 (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
    Tenosynovitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    0 / 50 (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
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Feeding intolerance
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         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
    Hyperchloraemia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Hypernatraemia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Hypokalaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Lactic acidosis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Metabolic acidosis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    4 / 50 (8.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Adenovirus infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Arthritis viral
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Bacteraemia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Catheter site infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Cellulitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         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
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Clostridium difficile infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Croup infectious
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Cystitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Device related infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    15 / 50 (30.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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 astroviral
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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 clostridial
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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 viral
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
    Gastrointestinal bacterial overgrowth
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Infectious mononucleosis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Influenza
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    6 / 50 (12.00%)
         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
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
    Malassezia infection
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
    Overgrowth bacterial
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 50 (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
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Pneumonia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Pneumonia viral
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Pulmonary mycosis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Rhinovirus infection
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Rotavirus infection
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 50 (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
    Sepsis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         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
    Septic shock
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Staphylococcal bacteraemia
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         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
    Urinary tract infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         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
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) Non-teduglutide/Teduglutide Treatment (NTT/TED) Teduglutide /Non-teduglutide Treatment (TED/NTT) Teduglutide/Teduglutide Treatment (TED/TED)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 7 (85.71%)
    3 / 3 (100.00%)
    1 / 1 (100.00%)
    50 / 50 (100.00%)
    Surgical and medical procedures
    Catheter removal
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General disorders and administration site conditions
    Catheter site discharge
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    0
    0
    1
    Catheter site extravasation
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Catheter site haemorrhage
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Complication associated with device
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    8 / 50 (16.00%)
         occurrences all number
    1
    0
    0
    9
    Influenza like illness
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Medical device site pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 3 (33.33%)
    1 / 1 (100.00%)
    16 / 50 (32.00%)
         occurrences all number
    2
    1
    1
    21
    Thirst
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Psychiatric disorders
    Learning disability
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Anastomotic ulcer
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    4
    Contusion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    0
    0
    0
    11
    Fall
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    0
    0
    1
    Gastrointestinal stoma complication
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    2
    0
    2
    Gastrostomy tube site complication
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    1
    0
    6
    Laceration
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    0
    0
    4
    Ligament sprain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Post procedural discomfort
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Procedural pain
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Skin abrasion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    0
    0
    6
    Soft tissue injury
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Stoma site reaction
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    1
    0
    0
    3
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    10 / 50 (20.00%)
         occurrences all number
    0
    0
    0
    16
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    0
    0
    4
    Blood 25-hydroxycholecalciferol increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood bicarbonate decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    0
    0
    4
    Blood bicarbonate increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    0
    1
    Blood triglycerides increased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood urea increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    0
    0
    4
    Blood urine present
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    3
    Body temperature increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    3
    C-reactive protein increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    8 / 50 (16.00%)
         occurrences all number
    0
    0
    0
    9
    Carcinoembryonic antigen increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Crystal urine present
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    3
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    0
    0
    6
    Gastrointestinal stoma output increased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    1
    0
    3
    Haemoglobin decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    0
    0
    4
    International normalised ratio increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    2
    4
    Lipase increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    0
    0
    4
    Prothrombin time prolonged
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    2
    4
    Transaminases increased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    0
    1
    White blood cells urine positive
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    3
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    1
    0
    4
    Coagulopathy
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    1
    2
    Lymphadenopathy
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    0
    0
    5
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cough
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 3 (66.67%)
    0 / 1 (0.00%)
    16 / 50 (32.00%)
         occurrences all number
    1
    3
    0
    41
    Epistaxis
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    2
    2
    0
    10
    Nasal congestion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    7 / 50 (14.00%)
         occurrences all number
    0
    0
    0
    11
    Oropharyngeal pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    1
    0
    0
    6
    Rhinitis allergic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    10 / 50 (20.00%)
         occurrences all number
    1
    2
    0
    26
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    1
    0
    0
    4
    Headache
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    11 / 50 (22.00%)
         occurrences all number
    0
    0
    0
    24
    Lethargy
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    3
    0
    0
    5
    Eye disorders
    Dry eye
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    4
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    6 / 50 (12.00%)
         occurrences all number
    0
    0
    0
    6
    Abdominal pain
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    15 / 50 (30.00%)
         occurrences all number
    4
    1
    0
    33
    Abdominal pain upper
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    7 / 50 (14.00%)
         occurrences all number
    1
    0
    0
    10
    Abnormal faeces
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Anal incontinence
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Colitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Constipation
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    3
    Diarrhoea
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    14 / 50 (28.00%)
         occurrences all number
    1
    2
    0
    29
    Enteritis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    0
    0
    1
    Flatulence
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    2
    0
    0
    3
    Frequent bowel movements
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    1
    0
    2
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haematochezia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    1
    0
    0
    6
    Nausea
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    7 / 50 (14.00%)
         occurrences all number
    1
    0
    0
    7
    Toothache
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vomiting
         subjects affected / exposed
    4 / 7 (57.14%)
    3 / 3 (100.00%)
    1 / 1 (100.00%)
    25 / 50 (50.00%)
         occurrences all number
    12
    11
    1
    77
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    4
    Nephrolithiasis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    0
    0
    1
    Product issues
    Device breakage
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    7 / 50 (14.00%)
         occurrences all number
    0
    0
    0
    12
    Device malfunction
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    1
    0
    0
    4
    Device occlusion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    0
    0
    0
    8
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    0
    0
    1
    Pain of skin
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rash
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    1 / 1 (100.00%)
    11 / 50 (22.00%)
         occurrences all number
    1
    2
    1
    20
    Rash erythematous
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rash papular
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    5 / 50 (10.00%)
         occurrences all number
    0
    0
    1
    7
    Tenosynovitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    3
    Decreased appetite
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    0
    0
    0
    5
    Dehydration
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    4
    Hyperchloraemia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    3
    Hypoglycaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    1
    0
    0
    2
    Hypokalaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    0
    0
    7
    Hyponatraemia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    3
    Metabolic acidosis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    5 / 50 (10.00%)
         occurrences all number
    0
    0
    1
    6
    Infections and infestations
    Device related infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    4
    Ear infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    0
    0
    0
    5
    Gastroenteritis viral
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    4
    Gastrointestinal bacterial overgrowth
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    0
    0
    7
    Influenza
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    0
    0
    0
    8
    Malassezia infection
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    9 / 50 (18.00%)
         occurrences all number
    1
    0
    0
    15
    Otitis media
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    1
    0
    0
    4
    Otitis media acute
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    5
    Respiratory tract infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    0
    0
    4
    Rhinitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    1 / 1 (100.00%)
    5 / 50 (10.00%)
         occurrences all number
    0
    1
    1
    9
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 7 (42.86%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    15 / 50 (30.00%)
         occurrences all number
    5
    1
    0
    41
    Urinary tract infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    15
    Varicella
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    1
    0
    0
    2
    Viral infection
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    9 / 50 (18.00%)
         occurrences all number
    2
    2
    0
    13
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    0
    0
    5

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Nov 2016
    Protocol Amendment 1: - The collection of all actual and prescribed EN data was removed to reduce the burden on the subjects and investigators. Enteral nutrition data are not required as the efficacy endpoints are limited to PS parameters. - Parental height and gestational age at birth were removed from medical history. - Changes were made to the Health economics and outcomes research endpoints to include the beginning of each treatment cycle (CxD1) as additional baseline. These changes were for clarity and consistency with other teduglutide studies.
    23 Mar 2017
    Protocol Amendment 2: - Revised the criteria for ET of the study: stopping criteria were extended to all NCI CTCAE Grade 3 and 4 severity events reported as related to the investigational product, and no longer limited to the events described in Table 8-1, titled “CTCAE Criteria for Adverse Events that May Lead to Dose Interruption (Prospective Period of Observation Only).”
    16 May 2018
    Protocol Amendment 3: - To minimize risk to subjects, a new escape criterion was added, allowing those who had escaped during the follow-up period of a previous teduglutide treatment to omit the follow-up period during subsequent teduglutide treatment cycles. For subjects who previously escaped the follow-up period, CxW24 assessments could be combined with the next pretreatment visit assessments. - Updated the information on the clinical studies with teduglutide in pediatric subjects to include the results of TED-C14-006 and a description of the additional core study, SHP633-301. - Added new PK simulation data to further support dosing. - Specified that an interim analysis was planned when 6 months of safety data had been collected for subjects entering from TED-C14-006. Additional interim analyses could be conducted as needed.
    01 Oct 2019
    Protocol Amendment 4: - Extended the planned study period to December 2020. - Clarification of the follow-up period escape criteria and their use in combining the CxW24 and pretreatment visits was added. - Clarified that AEs will be collected for 4 weeks after the last dose of teduglutide in the study even if the EOS/ET occurs within that timeframe. - The definition of an overdose was clarified as the administration of the investigational product at a dose or frequency greater than 0.05 mg/kg subcutaneous once daily. An overdose occurred if any of the following criteria were met: - More than 0.05 mg/kg was given at any one time - Consecutive doses were spaced less than 12 hours apart - Any more than 0.05 mg/kg given in one day - The teduglutide dose interruption criteria were updated to specify events leading to an interruption of teduglutide treatment and events leading to a permanent discontinuation of teduglutide treatment. Investigational product was interrupted if any of the following events occurred: - An AE of special interest - An AE that is of NCI CTCAE severity Grade 3 or 4 and related to teduglutide - Intestinal obstruction - Biliary obstruction related to teduglutide - Pancreatic duct obstruction related to teduglutide - Heart failure with severe fluid overload related to teduglutide. - Investigational product was permanently discontinued if any of the following events occurred: - Pregnancy - Severe hypersensitivity, such as anaphylaxis determined by the investigator to be related to study drug. This does not include the presence of anti-teduglutide antibodies, mild injection site reactions or mild symptoms that according to the investigator do not pose a significant risk to the subject. - Confirmed drug-induced liver injury (DILI) related to teduglutide. - Any malignancy.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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