Trial Outcomes & Findings for Study of Teduglutide in Japanese Participants With Short Bowel Syndrome (NCT NCT03663582)

NCT ID: NCT03663582

Last Updated: 2020-08-04

Results Overview

Change from baseline in weekly PS volume at EOT/ET was reported.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 7 participants
• Primary outcome timeframe: Baseline, EOT/ET (up to Week 28)
• Results posted on: 2020-08-04

Participant Flow

The study was conducted at 5 sites in Japan between 06 July 2018 (first participant first visit) and 06 August 2019 (last participant last visit).

A total of 7 participants were enrolled and received the treatment. Out of them, 6 participants completed the study.

Participant milestones

Measure	Teduglutide Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Overall Study STARTED	7
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Teduglutide Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Overall Study Physician Decision	1

Baseline Characteristics

Study of Teduglutide in Japanese Participants With Short Bowel Syndrome

Baseline characteristics by cohort

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Age, Continuous	40.4 years STANDARD_DEVIATION 8.92 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, EOT/ET (up to Week 28)

Population: ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit.

Change from baseline in weekly PS volume at EOT/ET was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET)	-2.92 Liter per week (L/Week) Standard Deviation 3.463

PRIMARY outcome

Timeframe: Baseline, EOT/ET (up to Week 28)

Population: ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit.

Percent change from baseline in weekly PS volume at EOT/ET was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET)	-22.19 Percent change Standard Deviation 24.953

PRIMARY outcome

Timeframe: Baseline, Week 20

Population: ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. Here, number of participants analyzed refer to the number of participants evaluable for this outcome measure.

Percentage of participants who achieved at least 20% reduction from baseline in weekly PS volume at Week 20 was reported.

Outcome measures

Measure	Teduglutide n=6 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 20	66.7 Percentage of participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. Here, number of participants analyzed refer to the number of participants evaluable for this outcome measure.

Percentage of participants who achieved at least 20% reduction from baseline in weekly PS volume at Week 24 was reported.

Outcome measures

Measure	Teduglutide n=6 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 24	66.7 Percentage of participants

PRIMARY outcome

Timeframe: Baseline, EOT/ET (up to Week 28)

Population: ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit.

Percentage of participants who achieve at least 20% reduction from baseline in weekly PS at EOT/ET was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) at End of Treatment/Early Termination (EOT/ET)	57.1 Percentage of participants

PRIMARY outcome

Timeframe: Baseline, EOT/ET (up to Week 28)

Population: ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit.

Change from baseline in days per week of PS at EOT/ET was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Change From Baseline in Days Per Week of Parenteral Support (PS) at End of Treatment/Early Termination (EOT/ET)	-0.43 Days per Week Standard Deviation 1.134

PRIMARY outcome

Timeframe: Baseline, EOT/ET (up to Week 28)

Population: ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit.

Plasma citrulline levels were measured as a biomarker of enterocyte mass. Change from baseline in plasma citrulline levels up to EOT/ET was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Change From Baseline in Plasma Citrulline Levels at End of Treatment/Early Termination (EOT/ET)	11.973 Micromoles (mcmol) Standard Deviation 11.7309

PRIMARY outcome

Timeframe: Week 24/EOT

Population: ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit.

Number of participants who were completely weaned off PS at Week 24/EOT was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Number of Participants Who Were Completely Weaned Off Parenteral Support (PS) at Week 24/End of Treatment (EOT) Weaned Off Parenteral Support: No	7 Participants
Number of Participants Who Were Completely Weaned Off Parenteral Support (PS) at Week 24/End of Treatment (EOT) Weaned Off Parenteral Support: Yes	0 Participants

PRIMARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12

Population: Pharmacokinetic (PK) population included all participants who received at least 1 dose of teduglutide and had at least 1 evaluable post-dose pharmacokinetic concentration value.

AUC0-t of teduglutide was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Area Under the Plasma Concentration-Time Curve From Zero to the Last Measurable Concentration (AUC0-t) of Teduglutide	240.3 Hour*nanogram per milliliter (h*ng/mL) Standard Deviation 80.651

PRIMARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12

Population: PK population included all participants who received at least 1 dose of teduglutide and had at least 1 evaluable post-dose pharmacokinetic concentration value.

Cmax of teduglutide was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Maximum Plasma Concentration (Cmax) of Teduglutide	49.50 Nanograms per milliliter (ng/mL) Standard Deviation 16.427

PRIMARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12

Population: PK population included all participants who received at least 1 dose of teduglutide and had at least 1 evaluable post-dose pharmacokinetic concentration value.

Tmax of teduglutide was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Time to Maximum Plasma Concentration (Tmax) of Teduglutide	3.00 Hour Interval 1.87 to 5.92

PRIMARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12

Population: PK population included all participants who received at least 1 dose of teduglutide and had at least 1 evaluable post-dose pharmacokinetic concentration value. Here, the number of participants analyzed refer to the number of participants evaluable for this outcome measure.

T1/2 of teduglutide was reported.

Outcome measures

Measure	Teduglutide n=6 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Terminal-phase Half-life (T1/2) of Teduglutide	1.09 Hour Interval 0.751 to 1.3

PRIMARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12

Population: PK population included all participants who received at least 1 dose of teduglutide and had at least 1 evaluable post-dose pharmacokinetic concentration value. Here, the number of participants analyzed refer to the number of participants evaluable for this outcome measure.

CL/F of teduglutide was reported.

Outcome measures

Measure	Teduglutide n=6 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Apparent Clearance (CL/F) of Teduglutide	10858.9 Milliliter per hour (mL/h) Standard Deviation 4038.5

PRIMARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12

Population: PK population included all participants who received at least 1 dose of teduglutide and had at least 1 evaluable post-dose pharmacokinetic concentration value. Here, the number of participants analyzed refer to the number of participants evaluable for this outcome measure.

Vz/F of teduglutide was reported.

Outcome measures

Measure	Teduglutide n=6 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Apparent Volume of Distribution (Vz/F) of Teduglutide	17167.4 Milliliter (mL) Standard Deviation 8371.9

PRIMARY outcome

Timeframe: From start of study drug administration up to EOT/ET (up to Week 28)

Population: Safety population included all participants in the ITT population who received at least 1 dose of study drug.

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs whose onset occurred, severity worsened, or intensity increased after receiving the study medication.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	7 Participants

PRIMARY outcome

Timeframe: From start of study drug administration up to EOT/ET (up to Week 28)

Population: Safety population included all participants in the ITT population who received at least 1 dose of study drug.

12-lead ECG was performed at the study center after the participant has been resting for at least 5 minutes. Number of participants with clinically significant abnormalities in 12-Lead ECG was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG)	0 Participants

PRIMARY outcome

Timeframe: Baseline, EOT/ET (up to Week 28)

Population: Safety population included all participants in the ITT population who received at least 1 dose of study drug.

Change from baseline in systolic and diastolic blood pressure at EOT/ET was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Change From Baseline in Blood Pressure at End of Treatment/Early Termination (EOT/ET) Systolic Blood Pressure: EOT (up to Week 28)	2.4 Millimetre of mercury (mmHg) Standard Deviation 19.37
Change From Baseline in Blood Pressure at End of Treatment/Early Termination (EOT/ET) Diastolic Blood Pressure: EOT (up to Week 28)	6.6 Millimetre of mercury (mmHg) Standard Deviation 20.59

PRIMARY outcome

Timeframe: Baseline, EOT/ET (up to Week 28)

Population: Safety population included all participants in the ITT population who received at least 1 dose of study drug.

Change from baseline in pulse rate at EOT/ET was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Change From Baseline in Pulse Rate at End of Treatment/Early Termination (EOT/ET)	2.6 Beats per minute (beats/min) Standard Deviation 9.88

PRIMARY outcome

Timeframe: Baseline, EOT/ET (up to Week 28)

Population: Safety population included all participants in the ITT population who received at least 1 dose of study drug.

Change from baseline in body temperature at EOT/ET was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Change From Baseline in Body Temperature at End of Treatment/Early Termination (EOT/ET)	-0.03 Degree Celsius Standard Deviation 0.411

PRIMARY outcome

Timeframe: Baseline, EOT/ET (up to Week 28)

Population: Safety population included all participants in the ITT population who received at least 1 dose of study drug.

Change from baseline in hemoglobin at EOT/ET was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Change From Baseline in Hemoglobin at End of Treatment/Early Termination (EOT/ET)	-3.9 Gram per liter (g/L) Standard Deviation 12.94

PRIMARY outcome

Timeframe: Baseline, EOT/ET (up to Week 28)

Population: Safety population included all participants in the ITT population who received at least 1 dose of study drug.

Change from baseline in hematocrit at EOT/ET was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Change From Baseline in Hematocrit at End of Treatment/Early Termination (EOT/ET)	-0.014 Volume per volume (v/v) Standard Deviation 0.0355

PRIMARY outcome

Timeframe: Baseline, EOT/ET (up to Week 28)

Population: Safety population included all participants in the ITT population who received at least 1 dose of study drug.

Change from baseline in serum blood urea nitrogen at EOT/ET was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Change From Baseline in Serum Blood Urea Nitrogen (BUN) at End of Treatment/Early Termination (EOT/ET)	0 mmol/L Standard Deviation 0

PRIMARY outcome

Timeframe: Baseline, EOT/ET (up to Week 28)

Population: Safety population included all participants in the ITT population who received at least 1 dose of study drug.

Change from baseline in creatinine at EOT/ET was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Change From Baseline in Creatinine at End of Treatment/Early Termination (EOT/ET)	-5.6 Micromoles per liter (mcmol/L) Standard Deviation 8.42

PRIMARY outcome

Timeframe: Baseline, EOT/ET (up to Week 28)

Population: Safety population included all participants in the ITT population who received at least 1 dose of study drug.

Change from baseline in urine sodium at EOT/ET was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Change From Baseline in Urine Sodium at End of Treatment/Early Termination (EOT/ET)	-2.1 millimoles per liter (mmol/L) Standard Deviation 64.92

PRIMARY outcome

Timeframe: EOT/ET (up to Week 28)

Population: Safety population included all participants in the ITT population who received at least 1 dose of study drug.

Number of participants who reported positive specific antibodies to teduglutide at EOT/ET was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at End of Treatment/Early Termination (EOT/ET)	1 Participants

PRIMARY outcome

Timeframe: Baseline, EOT/ET (up to Week 28)

Population: Safety population included all participants in the ITT population who received at least 1 dose of study drug.

Change from baseline in 48-hour urine output at EOT/ET was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Change From Baseline in 48-Hour Urine Output at End of Treatment/Early Termination (EOT/ET)	213.57 Milliliter per day (mL/day) Standard Deviation 242.757

PRIMARY outcome

Timeframe: Baseline, EOT/ET (up to Week 28)

Population: Safety population included all participants in the ITT population who received at least 1 dose of study drug.

Change from baseline in body weight at EOT/ET was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Change From Baseline in Body Weight at End of Treatment/Early Termination (EOT/ET)	0.164 kilogram (kg) Standard Deviation 1.1146

PRIMARY outcome

Timeframe: Baseline, EOT/ET (up to Week 28)

Population: Safety population included all participants in the ITT population who received at least 1 dose of study drug.

Change from baseline in BMI at EOT/ET was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Change From Baseline in Body Mass Index (BMI) at End of Treatment/Early Termination (EOT/ET)	0.07 Kilograms per square meter (kg/m^2) Standard Deviation 0.441

PRIMARY outcome

Timeframe: Week 24/ET

Population: Safety population included all participants in the ITT population who received at least 1 dose of study drug.

GI specific tests included colonoscopy or sigmoidoscopy, abdominal ultrasound, upper GI series with small bowel follow-through (UGI/SBFT). Number of participants with abnormal clinically significant changes in gastrointestinal specific tests at Week 24/ET was reported.

Outcome measures

Measure	Teduglutide n=7 Participants Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Number of Participants With Abnormal Clinically Significant Changes in Gastrointestinal (GI) Specific Tests at Week 24/ET (Early Termination)	0 Participants

Adverse Events

Teduglutide

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Teduglutide n=7 participants at risk Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Infections and infestations Device related infection	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Infections and infestations Medical device site infection	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Injury, poisoning and procedural complications Spinal compression fracture	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Nervous system disorders Epilepsy	14.3% 1/7 • Number of events 2 • From start of study drug administration up to EOT/ET (up to Week 28)

Other adverse events

Measure	Teduglutide n=7 participants at risk Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
Blood and lymphatic system disorders Anaemia	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Blood and lymphatic system disorders Polycythaemia	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Musculoskeletal and connective tissue disorders Back pain	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Vascular disorders Phlebitis	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Gastrointestinal disorders Abdominal distension	28.6% 2/7 • Number of events 2 • From start of study drug administration up to EOT/ET (up to Week 28)
Gastrointestinal disorders Abdominal pain	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Gastrointestinal disorders Abdominal pain lower	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Gastrointestinal disorders Gastrooesophageal reflux disease	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Gastrointestinal disorders Nausea	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
General disorders Injection site reaction	28.6% 2/7 • Number of events 2 • From start of study drug administration up to EOT/ET (up to Week 28)
General disorders Pyrexia	28.6% 2/7 • Number of events 2 • From start of study drug administration up to EOT/ET (up to Week 28)
Infections and infestations Nasopharyngitis	28.6% 2/7 • Number of events 2 • From start of study drug administration up to EOT/ET (up to Week 28)
Injury, poisoning and procedural complications Gastrointestinal stoma complication	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Injury, poisoning and procedural complications Muscle contusion	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Injury, poisoning and procedural complications Rib fracture	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Hepatobiliary disorders Cholelithiasis	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Metabolism and nutrition disorders Hypozincaemia	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Nervous system disorders Epilepsy	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Nervous system disorders Headache	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Reproductive system and breast disorders Menorrhagia	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Respiratory, thoracic and mediastinal disorders Epistaxis	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Skin and subcutaneous tissue disorders Dry skin	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)
Skin and subcutaneous tissue disorders Urticaria	14.3% 1/7 • Number of events 1 • From start of study drug administration up to EOT/ET (up to Week 28)

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: ClinicalTransparency@shire.com

Results disclosure agreements

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

Restriction type: OTHER