A Pharmacokinetic, Safety, and Pharmacodynamic Study of T... | NCT01952080

Label	Type	Description	Intervention Names
teduglutide	Experimental	Open label teduglutide, subcutaneously injected.	Drug: teduglutide
Standard of Care	No Intervention

Name	Type	Description	Arm Group Labels	Other Names
teduglutide	Drug	Open label intervention. Each subject will be assigned to receive 0.0125, 0.025, or 0.05 mg/kg/day for the duration of the study	teduglutide

Measure	Description	Time Frame
Percent Change in Parenteral Support [Parenteral Nutrition (PN)/Intravenous (IV)] Volume at Week 12	Percent change in PN/IV from the Baseline Visit to Week 12 Visit.	Baseline, Week 12
Percent Change in Parenteral Support (PN/IV) Volume at End of Treatment	Percent change in PN/IV from the Baseline Visit to End of Treatment Visit.	Baseline, End of Treatment
Percent Change in Parenteral Support (PN/IV) Volume at Week 16	Percent change in PN/IV from the Baseline Visit to Week 16 Visit.	Baseline, Week 16
Absolute Change in Parenteral Support (PN/IV) Volume at Week 12	Absolute change in PN/IV from the Baseline Visit to Week 12 Visit.	Baseline, Week 12
Absolute Change in Parenteral Support (PN/IV) Volume at End of Treatment	Absolute change in PN/IV from the Baseline Visit to End of Treatment Visit.	Baseline, End of Treatment
Absolute Change in Parenteral Support (PN/IV) Volume at Week 16	Absolute change in PN/IV from the Baseline Visit to Week 16 Visit.	Baseline, Week 16

Measure	Description	Time Frame
Percent Change in Enteral Support (EN) Volume From Baseline at Week 12	Percent change in enteral support requirements at Week 12 (liters/week)	Baseline, Week 12
Percent Change in Enteral Support (EN) Volume From Baseline at Week 16

Name	Affiliation	Role
Study Director	Takeda	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Children´s Hospital of Alabama		Birmingham	Alabama	35233	United States
Arkansas Children's Hospital

PubMed Identifier	Type	Citation	Retractions
37889619	Derived	Fifi A, Raphael BP, Terreri B, Uddin S, Kaufman SS. Effects of Teduglutide on Diarrhea in Pediatric Patients with Short Bowel Syndrome-Associated Intestinal Failure. J Pediatr Gastroenterol Nutr. 2023 Nov 1;77(5):666-671. doi: 10.1097/MPG.0000000000003922. Epub 2023 Aug 22.
27855998	Derived	Carter BA, Cohran VC, Cole CR, Corkins MR, Dimmitt RA, Duggan C, Hill S, Horslen S, Lim JD, Mercer DF, Merritt RJ, Nichol PF, Sigurdsson L, Teitelbaum DH, Thompson J, Vanderpool C, Vaughan JF, Li B, Youssef NN, Venick RS, Kocoshis SA. Outcomes from a 12-Week, Open-Label, Multicenter Clinical Trial of Teduglutide in Pediatric Short Bowel Syndrome. J Pediatr. 2017 Feb;181:102-111.e5. doi: 10.1016/j.jpeds.2016.10.027. Epub 2016 Nov 15.

ID	Title	Description
FG000	Standard of Care	SOC- no teduglutide therapy
FG001	Teduglutide 0.0125 mg/kg/Day	Cohort 1 - Teduglutide 0.0125 mg/kg/day

ID	Title	Description
BG000	Standard of Care	SOC- no teduglutide therapy
BG001	Teduglutide 0.0125 mg/kg/Day	Cohort 1 - Teduglutide 0.0125 mg/kg/day
BG002	Teduglutide 0.025 mg/kg/Day	Cohort 2 - Teduglutide 0.025 mg/kg/day
BG003	Teduglutide 0.05 mg/kg/Day	Cohort 3 - Teduglutide 0.05 mg/kg/day
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG0005 BG0018 BG00214 BG00315 BG00442

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent Change in Parenteral Support [Parenteral Nutrition (PN)/Intravenous (IV)] Volume at Week 12

Percent change in PN/IV from the Baseline Visit to Week 12 Visit.

Percent change in PN/IV volume from baseline to Week 12 based on prescribed data - Intent-to-Treat Population (ITT), defined as all participants who were enrolled in the study.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12

ID	Title	Description
OG000	Standard of Care	SOC- no teduglutide therapy
OG001	Teduglutide 0.0125 mg/kg/Day	Cohort 1 - Teduglutide 0.0125 mg/kg/day
OG002	Teduglutide 0.025 mg/kg/Day	Cohort 2 - Teduglutide 0.025 mg/kg/day
OG003	Teduglutide 0.05 mg/kg/Day	Cohort 3 - Teduglutide 0.05 mg/kg/day

Units	Counts
Participants	OG0005 OG0017 OG00213 OG003

Title

Denominators

Categories

Title	Measurements
	OG0007.38± 12.756 OG001-9.95± 21.625 OG002-37.34± 26.422 OG003

Primary

Percent Change in Parenteral Support (PN/IV) Volume at End of Treatment

Percent change in PN/IV from the Baseline Visit to End of Treatment Visit.

Percent change in PN/IV volume from baseline to End of Treatment based on prescribed data - Intent-to-Treat Population

Posted

Mean

Standard Deviation

percent change

Baseline, End of Treatment

ID	Title	Description
OG000	Standard of Care	SOC- no teduglutide therapy
OG001	Teduglutide 0.0125 mg/kg/Day	Cohort 1 - Teduglutide 0.0125 mg/kg/day
OG002	Teduglutide 0.025 mg/kg/Day	Cohort 2 - Teduglutide 0.025 mg/kg/day
OG003	Teduglutide 0.05 mg/kg/Day	Cohort 3 - Teduglutide 0.05 mg/kg/day

Units	Counts

Primary

Percent Change in Parenteral Support (PN/IV) Volume at Week 16

Percent change in PN/IV from the Baseline Visit to Week 16 Visit.

Percent change in PN/IV volume from baseline to Week 16 based on prescribed data - Intent-to-Treat Population

Posted

Mean

Standard Deviation

percent change

Baseline, Week 16

ID	Title	Description
OG000	Standard of Care	SOC- no teduglutide therapy
OG001	Teduglutide 0.0125 mg/kg/Day	Cohort 1 - Teduglutide 0.0125 mg/kg/day
OG002	Teduglutide 0.025 mg/kg/Day	Cohort 2 - Teduglutide 0.025 mg/kg/day
OG003	Teduglutide 0.05 mg/kg/Day	Cohort 3 - Teduglutide 0.05 mg/kg/day

Units	Counts

Primary

Absolute Change in Parenteral Support (PN/IV) Volume at Week 12

Absolute change in PN/IV from the Baseline Visit to Week 12 Visit.

Absolute change in PN/IV volume from baseline to Week 12 based on prescribed data - Intent-to-Treat Population

Posted

Mean

Standard Deviation

Liters/week

Baseline, Week 12

ID	Title	Description
OG000	Standard of Care	SOC- no teduglutide therapy
OG001	Teduglutide 0.0125 mg/kg/Day	Cohort 1 - Teduglutide 0.0125 mg/kg/day
OG002	Teduglutide 0.025 mg/kg/Day	Cohort 2 - Teduglutide 0.025 mg/kg/day
OG003	Teduglutide 0.05 mg/kg/Day	Cohort 3 - Teduglutide 0.05 mg/kg/day

Units	Counts

Other Pre-specified

Percent Change in Enteral Support (EN) Volume From Baseline at Week 12

Percent change in enteral support requirements at Week 12 (liters/week)

Percent change of EN volume from baseline to Week 12 based on subject diary data - Intent-to-Treat Population

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12

ID	Title	Description
OG000	Standard of Care	SOC- no teduglutide therapy
OG001	Teduglutide 0.0125 mg/kg/Day	Cohort 1 - Teduglutide 0.0125 mg/kg/day
OG002	Teduglutide 0.025 mg/kg/Day	Cohort 2 - Teduglutide 0.025 mg/kg/day
OG003	Teduglutide 0.05 mg/kg/Day	Cohort 3 - Teduglutide 0.05 mg/kg/day

Units	Counts

Other Pre-specified

Percent Change in Enteral Support (EN) Volume From Baseline at Week 16

Percent change in enteral support requirements at Week 16 (liters/week)

Percent change of EN volume from baseline to Week 16 based on subject diary data - Intent-to-Treat Population

Posted

Mean

Standard Deviation

percent change

Baseline, Week 16

ID	Title	Description
OG000	Standard of Care	SOC- no teduglutide therapy
OG001	Teduglutide 0.0125 mg/kg/Day	Cohort 1 - Teduglutide 0.0125 mg/kg/day
OG002	Teduglutide 0.025 mg/kg/Day	Cohort 2 - Teduglutide 0.025 mg/kg/day
OG003	Teduglutide 0.05 mg/kg/Day	Cohort 3 - Teduglutide 0.05 mg/kg/day

Units	Counts

Other Pre-specified

Absolute Change in Enteral Support (EN) Volume From Baseline at Week 12

Absolute change in enteral support requirements at Week 12 (liters/week)

Absolute change of EN volume from baseline to Week 12 based on subject diary data - Intent-to-Treat Population

Posted

Mean

Standard Deviation

Liters/week

Baseline, Week 12

ID	Title	Description
OG000	Standard of Care	SOC- no teduglutide therapy
OG001	Teduglutide 0.0125 mg/kg/Day	Cohort 1 - Teduglutide 0.0125 mg/kg/day
OG002	Teduglutide 0.025 mg/kg/Day	Cohort 2 - Teduglutide 0.025 mg/kg/day
OG003	Teduglutide 0.05 mg/kg/Day	Cohort 3 - Teduglutide 0.05 mg/kg/day

Units	Counts

Other Pre-specified

Absolute Change in Enteral Support (EN) Volume From Baseline at Week 16

Absolute change in enteral support requirements at Week 16 (liters/week)

Absolute change of EN volume from baseline to Week 16 based on subject diary data - Intent-to-Treat Population

Posted

Mean

Standard Deviation

Liters/week

Baseline, Week 16

ID	Title	Description
OG000	Standard of Care	SOC- no teduglutide therapy
OG001	Teduglutide 0.0125 mg/kg/Day	Cohort 1 - Teduglutide 0.0125 mg/kg/day
OG002	Teduglutide 0.025 mg/kg/Day	Cohort 2 - Teduglutide 0.025 mg/kg/day
OG003	Teduglutide 0.05 mg/kg/Day	Cohort 3 - Teduglutide 0.05 mg/kg/day

Units	Counts

Primary

Absolute Change in Parenteral Support (PN/IV) Volume at End of Treatment

Absolute change in PN/IV from the Baseline Visit to End of Treatment Visit.

Absolute change in PN/IV volume from baseline to End of Treatment based on prescribed data - Intent-to-Treat Population

Posted

Mean

Standard Deviation

Liters/week

Baseline, End of Treatment

ID	Title	Description
OG000	Standard of Care	SOC- no teduglutide therapy
OG001	Teduglutide 0.0125 mg/kg/Day	Cohort 1 - Teduglutide 0.0125 mg/kg/day
OG002	Teduglutide 0.025 mg/kg/Day	Cohort 2 - Teduglutide 0.025 mg/kg/day
OG003	Teduglutide 0.05 mg/kg/Day	Cohort 3 - Teduglutide 0.05 mg/kg/day

Units	Counts

Primary

Absolute Change in Parenteral Support (PN/IV) Volume at Week 16

Absolute change in PN/IV from the Baseline Visit to Week 16 Visit.

Absolute change in PN/IV volume from baseline to Week 16 based on prescribed data - Intent-to-Treat Population

Posted

Mean

Standard Deviation

Liters/week

Baseline, Week 16

ID	Title	Description
OG000	Standard of Care	SOC- no teduglutide therapy
OG001	Teduglutide 0.0125 mg/kg/Day	Cohort 1 - Teduglutide 0.0125 mg/kg/day
OG002	Teduglutide 0.025 mg/kg/Day	Cohort 2 - Teduglutide 0.025 mg/kg/day
OG003	Teduglutide 0.05 mg/kg/Day	Cohort 3 - Teduglutide 0.05 mg/kg/day

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pancytopenia	Blood and lymphatic system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG0031 events1 affected15 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003
Frequent Bowel Movement	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003
Pyrexia	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 events2 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003
Catheter related complication	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected5 at risk EG0010 affected8 at risk EG0022 events2 affected14 at risk EG003
Fatigue	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Irritability	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0010 events0 affected8 at risk EG0020 affected14 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Central line infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected8 at risk EG0025 events3 affected14 at risk EG003
Parainfluenzae virus infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003
Adenovirus infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 events1 affected8 at risk EG0020 affected14 at risk EG003
Catheter related infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 events1 affected8 at risk EG0020 affected14 at risk EG003
Catheter sepsis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Influenza	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 events1 affected8 at risk EG0020 affected14 at risk EG003
Rhinovirus infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003
Fungaemia	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Viral infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Blood creatinine increased	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Depressed level of consciousness	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Grand mal convulsion	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003
Hypovolemic shock	Vascular disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0022 events2 affected14 at risk EG0030 affected15 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0022 events2 affected14 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (12.0)	Non-systematic Assessment		EG0001 events1 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003
Eyes sunken	Eye disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0028 events5 affected14 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment		EG0001 events1 affected5 at risk EG0011 events1 affected8 at risk EG0025 events1 affected14 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0013 events1 affected8 at risk EG0022 events2 affected14 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment		EG0001 events1 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003
Faecal volume increased	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0011 events1 affected8 at risk EG0021 events1 affected14 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0012 events1 affected8 at risk EG0021 events1 affected14 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0012 events2 affected8 at risk EG0021 events1 affected14 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0012 events2 affected8 at risk EG0021 events1 affected14 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment		EG0002 events1 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Painful defaecation	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Retching	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0022 events2 affected14 at risk EG003
Catheter related complication	General disorders	MedDRA (12.0)	Non-systematic Assessment		EG0001 events1 affected5 at risk EG0014 events3 affected8 at risk EG0024 events4 affected14 at risk EG003
Pyrexia	General disorders	MedDRA (12.0)	Non-systematic Assessment		EG0003 events2 affected5 at risk EG0010 affected8 at risk EG0022 events2 affected14 at risk EG003
Fatigue	General disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003
Injection site haemorrhage	General disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0022 events2 affected14 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment		EG0002 events2 affected5 at risk EG0013 events2 affected8 at risk EG0026 events4 affected14 at risk EG003
Central line infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0025 events3 affected14 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment		EG0001 events1 affected5 at risk EG0011 events1 affected8 at risk EG0020 affected14 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0012 events2 affected8 at risk EG0020 affected14 at risk EG003
Influenza	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0011 events1 affected8 at risk EG0021 events1 affected14 at risk EG003
Overgrowth bacterial	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0012 events2 affected8 at risk EG0020 affected14 at risk EG003
Parainfluenzae virus infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003
Rhinovirus infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0022 events2 affected14 at risk EG003
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	Only 1 subject in each of the 3 dosing cohorts had a stoma and no standard of care subject had a stoma.	EG0000 affected0 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Feeding tube complication	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0022 events2 affected14 at risk EG003
Incision site erythema	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003
Blood bicarbonate decreased	Investigations	MedDRA (12.0)	Non-systematic Assessment		EG0002 events2 affected5 at risk EG0011 events1 affected8 at risk EG0021 events1 affected14 at risk EG003
Weight decreased	Investigations	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0011 events1 affected8 at risk EG0021 events1 affected14 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003
Bacteria urine	Investigations	MedDRA (12.0)	Non-systematic Assessment		EG0001 events1 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Blood urine present	Investigations	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Protein urine present	Investigations	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Red blood cells urine positive	Investigations	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
White blood cells urine positive	Investigations	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Anorexia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment		EG0001 events1 affected5 at risk EG0011 events1 affected8 at risk EG0020 affected14 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0011 events1 affected8 at risk EG0020 affected14 at risk EG003
Headache	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0015 events1 affected8 at risk EG0022 events2 affected14 at risk EG003
Dizziness	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment		EG0001 events1 affected5 at risk EG0013 events1 affected8 at risk EG0023 events2 affected14 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0022 events2 affected14 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected8 at risk EG0023 events1 affected14 at risk EG003
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment		EG0001 events1 affected5 at risk EG0010 affected8 at risk EG0021 events1 affected14 at risk EG003
Pallor	Vascular disorders	MedDRA (12.0)	Non-systematic Assessment		EG0001 events1 affected5 at risk EG0010 affected8 at risk EG0020 events0 affected14 at risk EG003
Fungaemia	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment		EG0002 events1 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Viral infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment		EG0001 events1 affected5 at risk EG0010 events0 affected8 at risk EG0020 events0 affected14 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment		EG0001 events1 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
White blood cell count increased	Investigations	MedDRA (12.0)	Non-systematic Assessment		EG0001 events1 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Urine leukocyte esterase positive	Investigations	MedDRA (12.0)	Non-systematic Assessment		EG0001 events1 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
C-reactive protein increased	Investigations	MedDRA (12.0)	Non-systematic Assessment		EG0001 events1 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Gastrointestinal bacterial infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment		EG0001 events1 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003
Irritability	General disorders	MedDRA (12.0)	Non-systematic Assessment		EG0001 events1 affected5 at risk EG0010 affected8 at risk EG0020 affected14 at risk EG003

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Standard of Care	SOC- no teduglutide therapy	3	5	5	5
EG001	Teduglutide 0.0125 mg/kg/Day	Cohort 1 - Teduglutide 0.0125 mg/kg/day	3	8	8	8
EG002	Teduglutide 0.025 mg/kg/Day	Cohort 2 - Teduglutide 0.025 mg/kg/day	6	14	14	14
EG003	Teduglutide 0.05 mg/kg/Day	Cohort 3 - Teduglutide 0.05 mg/kg/day	8	15	15	15